[Evaluation of advantages of Contractubex gel usage for postsurgical scars treatment in comparison with absence of systematized topical scars treatment of kids with congenital cleft lip and palate]. / Otsenka preimushchestv primeneniya gelya Kontraktubeks pri posleoperatsionnykh rubtsakh v sravnenii s otsutstviem sistematizirovannogo mestnogo lecheniya u detei s vrozhdennymi rasshchelinami verkhnei guby i neba.

OBJECTIVE: Is to evaluate the advantage of Contractubex gel with regards to influence on vascularisation, pigmentation, thickness, surface size, configuration, and elisticity of postsurgical scars of children (after cheilorinoplasty) in comparison to absence of systematized topical treatment. MATERIAL AND METHODS: Into the prospective, non-interventional, observational, multi-centered, in parallel groups, open, controlled study were included 60 patients aged 2,5 months and older with postsurgical scars after first cheilorinoplasty after 7-14 day after operation. Patients were randomized into 2 groups of 30 patients in each. I group - patients get applications of Contractubex gel 3 times a day (in the morning, in the afternoon, in the evening) in accordance with patient information leaflet. II group - control group with no regular therapy of of postsurgical scars (without treatment or without application of oils and gels with anticsarring action). The period of medicine usage - 9 months and more for each patient, the each patient observation duration is 18 months. RESULTS: After analysis of the primary as well as secondary efficacy criteria (total grade based on POSAS scale, reported by investigator/parent) after 3, 6, 12, 18 months of observation in both groups a positive statistically significant dynamics was registered. At the same time in the Contractubex group results were statistically significantly better than in the control group. Positive dynamics was achieved quickier in the main group than in the contol group and was to observe already after 3 months of therapy, during the whole treatment and observation phase, and after 18 months of therapy. Additionally conducted photodocumentation of postsurgical scar development dynamics in terms of the study confirms positive effect of surgery and absence of visual data regarding keloids or hyperthrophic scars formation in patients in both groups. Adverse events, i. a. pain, itch, burning, long-run hyperemia were not registered during the whole period os study. CONCLUSION: The conducted study has shown high efficacy and safety of Contractubex usage for the treatment of postsurgical scars of children with with congenital cleft lip and palate (from 2,5 months old). The statistically significant advantage of the therapy with Contractubex was demonstrated in comparison with the control group (with no regular topical treatment). The obtained results allow to recommend Contractubex gel as an effective and safe medicine for the treatment of scarring after surgeries for kids directly after sutures removal.

Dressings and topical agents for preventing pressure ulcers.

BACKGROUND: Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013. OBJECTIVES: To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting. SEARCH METHODS: In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification. SELECTION CRITERIA: We included randomised controlled trials that enrolled people at risk of pressure ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias and extracted data. MAIN RESULTS: The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (DermalexTM 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the DermalexTM group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision). AUTHORS' CONCLUSIONS: Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.

Comparison of the Effects of Contractubex Gel and Benzothiazole After Topical Application in an Experimental Model of Epidural Fibrosis in Rats.

BACKGROUND: Postoperative epidural adhesion is a frequent cause of failed back surgery syndrome, manifesting with back and leg pain or neurologic deficits. Development of preventive measures for epidural adhesion after laminectomy is critical to improve outcomes of lumbar surgery. We hypothesized that positive effects of topical application of Contractubex (CTX) gel and benzothiazole (BT) individually and in combination could aid in preventing epidural fibrosis in a rat laminectomy model. METHODS: Rats were randomly assigned to 2 control and 5 experimental groups (n = 8 for each group). The control(-) group received no surgery, whereas the control(+) group underwent laminectomy without any drug administration. In experimental groups, study agents applied to dura mater after laminectomy were 100mgCTX, 2.5%BT, 5%BT; 100mgCTXplus2.5%BT, and 100mgCTXplus5%BT. Laminectomy was performed at the L3 level for all rats. The extent of epidural fibrosis was assessed 4 weeks later macroscopically and histopathologically. Hepatic and renal toxicity of study drugs was assessed histopathologically. RESULTS: Topical CTX and BT individually and in combination reduced epidural fibrosis after laminectomy in rats. Although a meaningful decrease of epidural fibrosis with individual application of CTX and BT (2.5% or 5%) was obtained (P < 0.05), the effect of their combination was more pronounced without meaningful hepatic and renal toxicity (P < 0.05). CONCLUSIONS: Combined use of topical CTX and BT could be a potential therapy for epidural fibrosis. Further research with this agents for the prevention of epidural fibrosis is warranted.

[A new approach in the compression therapy of postoperative scars]. / Novyi podkhod v kompressionnoi terapii posleoperatsionnykh rubtsov.

The aim of the study was to evaluate the effectiveness of compression therapy with a prolonged plaster of Contractubex in the formation of skin scarring in children after surgery. MATERIAL AND METHODS: In a prospective open-label randomized trial, 109 patients aged 5.3±2.1 years after surgery: boys - 73, girls - 36. Patients were divided into 2 groups: in the main group (54 children) the application of the prolonged plaster Contractubex was performed; in the control group (55 patients) - dynamic observation. The scar deformation was assessed according to the Vancouver scale for 10, 30 and 90 postoperative days. RESULTS: 94.4% patients had good compliance; in 2 (3.7%) - satisfactory; in 1 (1.9%) - unsatisfactory compliance. In our study, the formation of hypertrophic scars in the main group was significantly less frequent than in the control group (1 and 8 patients, respectively, χ2=4.241, p=0.042). CONCLUSION: Thus, the use of the prolonged plaster Contractubex in the near and distant period a good cosmetic and functional result in the formation of a postoperative scar was provided.

The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction

BACKGROUND: Despite efforts to prevent postoperative discomfort, there are still many immediate side effects associated with the surgical extraction of impacted lower third molars. Cicatrization is a physiological process through which the loss of integrity of oral mucosa is recovered and damaged tissues are repaired. Bexident Post (ISDIN, Spain) is a topical gel that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. While this gel has many clinical indications, there are no published clinical trials evaluating its use in impacted mandibular third molar surgery. This study aims to clinically evaluate the efficacy of a gel containing chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol on wound healing and reduction of postoperative side effects and complications after extraction of an impacted mandibular third molar. MATERIAL AND METHODS: A split-mouth design study was carried out on a total of 50 bilaterally and symmetrically impacted third molar extractions, which were randomly placed into either a control group (CG=25) or an experimental group (EG=25). Patients were all informed of the purpose of the study and provided written consent. All procedures were carried out by the same dental practitioner, in accordance with standard surgical protocol. A different dental practitioner, unaware of which treatment had been applied, provided follow-up care. The EG applied 10 ml of topical gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol to the surgical wound three times a day for 10 days, patients in the CG did not apply any gel. RESULTS: The groups were homogeneous insofar as potentially confounding variables. No significant findings were found regarding postoperative swelling and pain. Neither of the groups displayed poor healing or infectious complications of the wound during the postoperative period. In all the recorded follow-ups (Day 7 p = 0.001, and Day 14 p = 0.01), the wound's aesthetic appearance was better in the EG. Overall treatment tolerance was satisfactory and similar in both groups. CONCLUSIONS: The gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol did not aid in patients' postoperative comfort; however, improved wound healing was observed

Combination of argan oil and phospholipids for the development of an effective liposome-like formulation able to improve skin hydration and allantoin dermal delivery.

Allantoin is traditionally employed in the treatment of skin ulcers and hypertrophic scars. In the present work, to improve its local deposition in the skin and deeper tissues, allantoin was incorporated in conventional liposomes and in new argan oil enriched liposomes. In both cases, obtained vesicles were unilamellar, as confirmed by cryo-TEM observation, but the addition of argan oil allowed a slight increase of the mean diameter (∼130nm versus ∼85nm). The formulations, especially those containing argan oil, favoured the allantoin accumulation in the skin, in particular in the dermis (∼8.7µg/cm(2)), and its permeation through the skin (∼33µg/cm(2)). The performances of vesicles as skin delivery systems were compared with those obtained by water dispersion of allantoin and the commercial gel, Sameplast(®). Moreover, in this work, for the first time, the elastic and viscous moduli of the skin were measured, underlining the different hydrating/moisturizing effects of the formulations. The application of ARG liposomes seems to provide a softening and relaxing effect on the skin, thus facilitating the drug accumulation and passage into and trough it.

Topical management of striae distensae (stretch marks): prevention and therapy of striae rubrae and albae.

Striae distensae (SD) are common dermal lesions, with significant physical and psychological impact. Many therapeutic modalities are available but none can completely eradicate SD. The most common therapy is the application of topicals used both therapeutically and prophylactically. Even though there are many commercially available topical products, not all have sufficient level of evidence to support their continued use in SD. The aim here was to assess the evidence for the use of topicals in SD and to propose a structured approach in managing SD. A systematic search of published literature and manufacturer website information for topicals in SD was carried out. The results showed that there are few studies (n = 11) which investigate the efficacy of topicals in management of SD. Trofolastin and Alphastria creams demonstrated level-2 evidence of positive results for their prophylactic use in SD. Additionally, tretinoin used therapeutically showed varying results whilst cocoa butter and olive oil did not demonstrate any effect. Overall, there is a distinct lack of evidence for each topical formulation. The majority of topicals failed to mention their effect on early vs. later stages of SD (striae rubrae compared to striae albae) and their role in both prevention and treatment. In conclusion, there is no topical formulation, which is shown to be most effective in eradicating or improving SD. A structured approach in identification and targeted management of symptoms and signs with the appropriate topical is required. Randomized controlled trials are necessary to assess the efficacy of topical products for treatment and prevention of different stages of SD.

Efficacy of chlorhexidine, dexpanthenol, allantoin and chitosan gel in comparison with bicarbonate oral rinse in controlling post-interventional inflammation, pain and cicatrization in subjects undergoing dental surgery.

INTRODUCTION: Reducing post-interventional inflammation and pain in odontostomatological surgery procedures, such as tooth extractions, implants or oral biopsies is a relevant clinical goal. Chlorhexidine oral rinse is commonly used with this aim. Recently a new product containing chlorhexidine, dexpanthenol, allantoin and chitosan (Bexident Post [BP]) in a gel formulation has been developed. We evaluated the efficacy of BP in controlling postsurgical inflammation and pain and in promoting cicatrization in subjects undergoing molar extractions. SUBJECTS AND METHODS: We conducted a prospective sequential cross-over, randomized controlled study in patients undergoing surgical removal of at least two impacted mandibular third molars (teeth numbers 38 and 48) (numbers 17 and 32 in the Universal Tooth Numbering System), in two separate sessions, to determine the effect of BP in comparison with bicarbonate (BC) oral rinse (one spoonful in 200 ml of water), both used three times daily. Each subject utilized both products in a randomized sequential manner after each tooth extraction. Primary outcomes of the study were post-procedure pain and inflammation. Secondary outcomes were analgesic pill rescue use (metamizole 1 cap every 8 hours if needed) and an assessor-blinded evaluation of cicatrization with a semi-quantitative scale (good, satisfactory and insufficient). Post-procedure pain was assessed 6 hours after tooth extraction and for seven consecutive days by means of a 10 cm visual analogue scale (VAS) (from 0: no pain to 10: extreme pain). The extent of inflammation was evaluated through metric measurements of facial perimeter using standardized anatomical reference points. RESULTS: A total of 47 patients (22 men and 25 women; mean age 34 years) were enrolled with a total of 94 molars extracted. Nineteen subjects applied BC as the first sequential treatment and 28 BP as the first. Before surgery no mean differences in the two treatments in inflammation measurements were observed. After surgery mean VAS pain score was similar between the two treatments in the first 6 hours (VAS score = 6.5). A marked progressive reduction in pain intensity with the use of BP was observed throughout the treatment period in comparison with BC (7 day mean scores 3.7 vs. 5.3; p = 0.0001). BP was superior to BC in reducing inflammation with -50% of the inflammation-related measurement (6 mm vs. 12 mm; p = 0.0001). Analgesic pill consumption was lower with BP in comparison with BC (13 pills vs. 24; p < 0.05). Cicatrization was scored 'good' in a higher percentage of subjects during BP use (64%) in comparison with the BC group (13%) (p = 0.0001). No serious side effects were reported with either treatment regimen. CONCLUSION: In this trial BP performed better than BC in controlling pain and inflammation in subjects undergoing dental surgery, reducing the consumption of analgesics and favoring better cicatrization.

Solid lipid nanoparticles containing copaiba oil and allantoin: development and role of nanoencapsulation on the antifungal activity.

The aim of this work was to develop solid lipid nanoparticles (SLN) containing copaiba oil with and without allantoin (NCOA, NCO, respectively) and to evaluate their antifungal activity. Nanoparticle suspensions were prepared using a high homogenisation technique and characterised by dynamic light scattering, laser diffraction, nanoparticle tracking analysis, multiple light scattering analysis, high-pressure liquid chromatography, pH and rheology. The antifungal activities of the formulations were tested in vitro against the emergent yeasts Candida krusei and Candida parapsilosis, and the fungal pathogens of human skin Trichophyton rubrum and Microsporum canis. The dynamic light scattering analysis showed z-average diameters (intensity) between 118.63 ± 8.89 nm for the nanoparticles with both copaiba oil and allantoin and 126.06 ± 9.84nm for the nanoparticles with just copaiba oil. The D[4,3] determined by laser diffraction showed similar results of 123 ± 1.73 nm for the nanoparticles with copaiba oil and allantoin and 130 ± 3.6 nm for the nanoparticles with copaiba oil alone. Nanoparticle tracking analysis demonstrated that both suspensions had monomodal profiles and consequently, the nanoparticle populations were homogeneous. This analysis also corroborated the results of dynamic light scattering and laser diffraction, exhibiting a smaller mean diameter for the nanoparticles with copaiba oil and allantoin (143 nm) than for the nanoparticles with copaiba oil (204 nm). The physicochemical properties indicated that the dispersions were stable overtime. Rheology evidenced Newtonian behaviour for both suspensions. Antifungal susceptibility showed a MIC90 of 125 µg/mL (nanoparticles with copaiba oil) and 7.8 µg/mL (nanoparticles with copaiba oil and allantoin) against C. parapsilosis. The nanoparticles with copaiba oil and the nanoparticles with copaiba oil and allantoin presented a MIC90 of 500 µg/mL and 250 µg/mL, respectively, against C. krusei. The MIC90 values were 500 µg/mL (nanoparticles with copaiba oil) and 1.95 µg/mL (nanoparticles with copaiba oil and allantoin) against T. rubrum. Against M. canis, the nanoparticles with copaiba oil and allantoin had a MIC9 of 1.95 µg/mL. In conclusion, nanoencapsulation improved the antifungal activity of copaiba oil, which was enhanced by the presence of allantoin. The MICs obtained are comparable to those of commercial products and can represent promising therapeutics for cutaneous infections caused by yeasts and dermatophytes.

Treatment of ocular surface squamous neoplasia with topical Aloe vera drops.

PURPOSE: To report a case of ocular surface squamous neoplasia (OSSN) that resolved with topical Aloe vera eye drop treatment. METHODS: A 64-year-old Hispanic woman with a lesion typical for OSSN in her left eye was followed up with multiple clinical examinations and ocular surface photographs to document changes over time with A. vera-based topical treatment. RESULTS: The patient refused biopsy of her lesion and traditional treatments and, instead, initiated using A. vera eye drops 3 times daily. At follow-up visits, the lesion was noted to regress until it finally resolved 3 months after commencing treatment. No additional topical medications were used, and she has remained tumor free for 6 years. CONCLUSIONS: Ongoing research is warranted because A. vera may represent a new therapeutic class of medications for OSSN treatment.

Natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer: a phase 3, double-blind, randomized, controlled trial.

PURPOSE: To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions. METHODS AND MATERIALS: A total of 174 patients were randomized and participated in the study. Patients received either cream 1 (the natural oil-based emulsion containing allantoin) or cream 2 (aqueous cream). Skin toxicity, pain, itching, and skin-related quality of life scores were collected for up to 4 weeks after radiation treatment. RESULTS: Patients who received cream 1 had a significantly lower average level of Common Terminology Criteria for Adverse Events at week 3 (P<.05) but had statistically higher average levels of skin toxicity at weeks 7, 8, and 9 (all P<.001). Similar results were observed when skin toxicity was analyzed by grades. With regards to pain, patients in the cream 2 group had a significantly higher average level of worst pain (P<.05) and itching (P=.046) compared with the cream 1 group at week 3; however, these differences were not observed at other weeks. In addition, there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 (P=.056). Overall, more participants in the cream 1 group were required to use another topical treatment at weeks 8 (P=.049) and 9 (P=.01). CONCLUSION: The natural oil-based emulsion containing allantoin seems to have similar effects for managing skin toxicity compared with aqueous cream up to week 5; however, it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion (week 6 and beyond). There were no major differences in pain, itching, and skin-related quality of life. In light of these results, clinicians and patients can base their decision on costs and preferences. Overall, aqueous cream seems to be a more preferred option.

Elastosis perforans serpiginosa: a case successfully treated with intralesional steroids and topical allium cepa-allantoin-pentaglycan gel.

Elastosis perforans serpiginosa is a rare skin disease in which abnormal elastic fibers, other connective tissue elements, and cellular debris are expelled from the papillary dermis through the epidermis. Three clinical variants of EPS can be detected: idiopathic, reactive, and drug-induced. Clinically it consists of small horny or umbilicated papules arranged in a linear, arciform, circular, or serpiginous pattern. It usually occurs in young adults and shows a predilection for the head and neck. The lesions are generally asymptomatic or slightly itching. Several treatments have been reported with poor long-term success; these include intralesional and topical corticosteroids, tazarotene, imiquimod, and cryotherapy. We report a case of 40-year-old black woman affected by elastosis perforans serpiginosa that was referred to our department and treated with intralesional injections of triamcinolone acetonide and topical application of allium cepa-allantoin-pentaglycan gel.

Scar prevention and remodeling: a review of the medical, surgical, topical and light treatment approaches.

Cosmetic, functional, and structural sequelae of scarring are innumerable, and measures exist to optimize and ultimately minimize these sequelae. To evaluate the innumerable methods available to decrease the cosmetic, functional, and structural repercussions of scarring, pubMed search of the English literature with key words scar, scar revision, scar prevention, scar treatment, scar remodeling, cicatrix, cicatrix treatment, and cicatrix remodeling was done. Original articles and reviews were examined and included. Seventy-nine manuscripts were reviewed. Techniques, comparisons, and results were reviewed and tabulated. Overall, though topical modalities are easier to use and are usually more attractive to the patient, the surgical approaches still prove to be superior and more reliable. However, advances in topical medications for scar modification are on the rise and a change towards medical treatment of scars may emerge as the next best approach. Comparison studies of the innumerable specific modalities for scar revision and prevention are impossible. Standardization of techniques is lacking. Scarring, the body's natural response to a wound, can create many adverse effects. At this point, the practice of sound, surgical fundamentals still trump the most advanced preventative methods and revision techniques. Advances in medical approaches are available, however, to assist the scarring process, which even the most advanced surgical fundamentals will ultimately lead to. Whether through newer topical therapies, light treatment, or classical surgical intervention, our treatment armamentarium of scars has expanded and will allow us to maximize scar prevention and to minimize scar morbidity.

The prophylactic use of a topical scar gel containing extract of Allium cepae, allantoin, and heparin improves symptoms and appearance of cesarean-section scars compared with untreated scars.

BACKGROUND: Abdominal Cesarean sections (C-sections) are frequently associated with an increased risk of excessive or unpleasant scarring. A topical scar gel containing extract of Allium cepae, allantoin and heparin (Contractubex®; Merz Pharmaceuticals GmbH, Germany), has shown efficacy in improving the appearance of various scar types. OBJECTIVE: To investigate the efficacy of the topical scar gel, Contractubex, in the early treatment of C-section scars. MATERIALS & METHODS: A total of 61 females, aged ≥18 years, who had given birth by elective C-section for the first time within the last 5-10 days, were included in this prospective, randomized, single-center study. Patients were advised to apply the topical scar gel twice daily (treatment group), or received no treatment (control group). Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment tool comprised of a Patient Scale and an Observer Scale. RESULTS: Analysis revealed a significant change in the POSAS Patient Scale total score, with a 14.2% improvement in the treatment group compared with a decline of similar magnitude (-14.8%) in the control group at week 6. Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color (13.6% vs -18.5%, respectively, P=0.0284), stiffness (12.5% vs -34.6%, respectively, P=0.0029), and irregularity (29.4% vs -46.2%, respectively, P=0.0140) after 6 weeks of treatment. No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel, although there was a strong overall trend in favor of the treatment group. No significant adverse events were observed during the study. CONCLUSION: Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color, stiffness and irregularity of C-section scars.

The effects of heat on skin barrier function and in vivo dermal absorption.

Enhanced delivery of ingredients across the stratum corneum (SC) is of great interest for improving the efficacy of topically applied formulations. Various methods for improving dermal penetration have been reported including galvanic devices and micro-needles. From a safety perspective it is important that such approaches do not compromise SC barrier function. This study investigates the influence of topically applied heat in vivo on the dermal uptake and penetration of a model active, allantoin from gel and lotion formulations. A custom designed device was used to deliver 42°C for 30s daily to human subjects after application of two formulations containing allantoin. The results were compared with sites treated with formulations containing no active and no heat, and a control site. In addition to penetration of allantoin, the integrity of the SC was monitored using trans-epidermal water loss (TEWL) measurements. The results showed that just 30s of 42°C topically applied heat was enough to cause significantly more penetration of allantoin from the lotion formulation compared with no application of heat. TEWL data indicated that the integrity of the skin was not compromised by the treatment. However, the application of heat did not promote enhanced penetration of the active from the gel formulation. Vehicle composition is therefore an important factor when considering thermal enhancement strategies for targeting actives to the skin.

Efficacy of early initiation of a gel containing extractum cepae, heparin, and allantoin for scar treatment: an observational, noninterventional study of daily practice.

BACKGROUND: Contractubex® (Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a gel containing extractum cepae, heparin, and allantoin with proven efficacy in the prevention of excessive scarring and promotion of physiological scar formation. AIM: To investigate the efficacy of early initiation of Contractubex in the prevention of excessive scarring and promotion of physiological scar formation. METHODS: In total, 1,268 patients were included in this observational, noninterventional study. Patients were assessed at visit 1 (within 3 weeks of the injury), when treatment was initiated, with subsequent assessments after 2 to 3 months of treatment, and at the end of the study (after 4 to 5 months of treatment). Parameters measured included scar size, color, and pliability (consistency/hardness), as well as patients' and physicians' subjective assessments of treatment efficacy and tolerability. RESULTS: After 2 to 3 months of treatment, there were statistically significant improvements in color and pliability of the scar, sensation of pain, tension, and pruritus compared with visit 1 (P<.0001). By the end of the study, further statistically significant improvements compared with visit 1 were observed for all parameters. Only about 1% of scars were rated as markedly red or markedly hardened at the final visit. In addition, there was a reduction of 31.5% in mean scar width and of 47.8% in mean scar height at the end of the observation period. A high percentage of patients (85.8%) and physicians (86.6%) rated the treatment as good or very good with respect to prevention of excessive scarring and promotion of physiological scar development. Tolerability was described as good or very good by 92.0% of physicians and 91.5% of patients. CONCLUSIONS: The results of this study suggest that the scar gel is effective in preventing excessive scarring and promoting physiological scar formation when treatment is initiated early. In addition, the treatment was well tolerated.

Effects of Noscarna™ on hypertrophic scarring in the rabbit ear model: histopathological aspects.

In this study, we evaluated the effects of silicone-based gel on the healing of hypertrophic scars in the rabbit ear model. After 4-week application of silicone-based gel containing allantoin, dexpanthenol and heparin (Noscarna™) to scars in a rabbit ear model of hypertrophic scarring, significant improvements in hypertrophic scar healing and a great loss of skin pigment were observed compared to the non-treated control, base or silicone control-treated scars. Furthermore, histological analysis of Noscarna™-treated scars revealed a significant reduction in scar elevation index (SEI), anterior skin and epithelial thicknesses, inflammatory cells, vessels, collagen disorganization and fibroblasts compared to all control hypertrophic scars. Furthermore, Noscarna™ showed more favorable effects on hypertrophic scars than a commercial product, Contractubex®. Therefore, these results clearly demonstrated that the newly developed silicone-based gel, Noscarna™, could be a promising formulation as an effective therapeutic agent for hypertrophic scars.

Comparison of the effects of Contractubex® gel in an experimental model of scar formation in rats: an immunohistochemical and ultrastructural study.

BACKGROUND: Contractubex® gel, a commercial treatment for scars, consists of a mixture of onion extract (cepea extract), heparin sodium, and allantoin. It exerts a softening and smoothing effect on indurated, hypertrophic, painful, and cosmetically-disfiguring scar tissue. AIM: To compare and discuss the immunohistochemical and ultrastructural effects of treatment of an experimental scar in a rat model with Contractubex gel. METHODS: Thirty-two Sprague-Dawley rats were divided into four groups. Skin biopsies were taken to develop full thickness wounds. After 10 days, Contractubex gel, heparin, and allantoin were topically applied daily to groups 2, 3, and 4, respectively. Group 1 was the control group. On the 30th day, scar tissues were excised to investigate the immunohistochemical and ultrastructural effects of these agents. For this purpose we used TGF-beta, laminin, and fibronectin primary antibodies. RESULTS: Increased immunoreactivities of laminin, fibronectin, and TGF-beta in control group, moderate immunoreactivities in heparin and allantoin groups, and mild immunoreactivities in the Contractubex gel group were observed. In semi-thin sections, Group 2 showed the thinnest epidermis of the four groups. In electron micrographs of Group 2, completely keratinized and normally appearing cells could be seen. CONCLUSIONS: Immunohistochemical and ultrastructural observations demonstrated that the Contractubex gel significantly improved the quality of wound healing and reduction of scar formation. Also, it was a more appropriate treatment choice than heparin monotherapy and allantoin monotherapy in keloidal and hypertrophic scars.