Blockade of melanin synthesis, activation and distribution pathway by a nonprescription natural regimen is equally effective to a multiple prescription-based therapeutic regimen.

BACKGROUND: Disorders characterized by cutaneous hyperpigmentation (HP) are among the most common complaints in dermatologists' offices. These patients are also some of the most difficult to treat since current therapeutic regimens have high irritation rates and mediocre efficacy. Moreover, current regimens have the potential to induce post-inflammatory HP (PIH), a secondary disease that is more difficult to treat. OBJECTIVE: To measure the effectiveness of a novel blend of primarily natural ingredients that inhibits all but one of the steps in melanin synthesis, activation and distribution. Three common types of HP were treated and compared with one of the most commonly prescribed available regimens. This comprises two prescription products and two nonprescription products containing known depigmenting lightening ingredients. MATERIALS AND METHODS: The initial trial consisted of 56 females of 3 different races were treated in a 3-armed parallel, investigatorblinded prospective controlled clinical trial of 18 weeks duration. The treatment phase was 12 weeks long, followed by a 6 week, nontreatment regression phase. This trial was conducted in the winter at over 6,000 feet above sea level. The natural ingredient (NI) blend consists of two cosmeceutical products together containing 22 ingredients. A second 1-year open trial of 31 panelists of 3 races was instituted to document continual improvement using both NI products without irritation and sensitization. RESULTS: The novel herbal blend regimens had comparable efficacy in treating HP and preventing rebound of mottled HP, dyschromia and melasma as the commercial regimen containing two prescription products. The 12-month open study demonstrated continued visible improvement of the HP with NI regimens without irritation and sensitization. CONCLUSION: The novel primarily natural ingredient product regimens are equally effective in treating three types of cutaneous HP as is a regimen containing prescription hydroquinone 4%, tretinoin 0.05% and two nonprescription leave on products.

Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study.

Improving skin barrier function and moisturizing without irritation are important components of managing patients with atopic dermatitis. This study evaluated the safety and tolerability of a body wash and moisturizer regimen for infants and toddlers with atopic dermatitis. This was an open-label study involving 56 children (3-36 months old) with a history of atopic dermatitis. The skin care regimen (Cetaphil Restoraderm Skin Restoring Body Wash and Cetaphil Restoraderm Skin Restoring Moisturizer; Galderma Laboratories, L.P.) was used at least once daily, but no more than twice daily, for 4 weeks. The primary variable of interest was the worst postbaseline scores for local tolerability (expressed as success or failure) using a 4-point scale for each component (erythema, edema, scaling and dryness, rash, and signs of discomfort upon application). Assessments of moisture content of the stratum corneum and transepidermal water loss were also performed. Fifty-three children completed the study. The percentage of subjects with no erythema increased from 33.9% to 50.0% by Week 4. The percentage of subjects with no scaling or dryness increased from 58.9% to 85.2% at Week 4. A statistically significant increase in corneometry from baseline (p < 0.001) and a statistically significant decrease in transepidermal water loss (p = .009) were observed. The body wash and moisturizer regimen was safe and well tolerated and improved hydration and skin barrier function in infants and toddlers as young as 3 months of age with a history of atopic dermatitis.

A comparison of the tolerability of adapalene 0.1% cream and adapalene 0.1% lotion in healthy individuals.

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

A randomized, double-blind, controlled comparative trial of the anti-aging properties of non-prescription tri-retinol 1.1% vs. prescription tretinoin 0.025%.

Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription. A randomized, double-blind, controlled clinical study was conducted to compare the efficacy and tolerability of a tri-retinol 1.1% gradual release cream vs. tretinoin 0.025% cream in females with mild-to-moderate facial photodamage. Subjects applied the test product to the entire face in the evening after cleansing in a progressively increasing frequency starting twice weekly for the first week, followed by three times weekly during the second week and then daily as tolerated for the third week and beyond. Treatment was continued for a total of three months. Clinical evaluations and standardized digital photographs were performed at baseline and after four, eight, and 12 weeks of treatment. Self-assessment questionnaires were completed by the subjects at four, eight, and 12 weeks to assess perceived efficacy of the test products. Thirty-four subjects (16: tri-retinol and 18: tretinoin) completed the study. Both test products significantly improved signs of photodamage, including fine and coarse periocular wrinkles, skin firmness, skin tone, mottled pigmentation, tactile roughness, overall photodamage and global photodamage improvement. There were no significant differences in efficacy between the two products for these assessments. The adverse effects (which were graded as mild or less) were those typically seen with topical retinoids. Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.

Randomized Controlled Trial of Desonlde Hydrogel 0.05% versus Desonide Ointment 0.05% in the Treatment of Mild-to-moderate Atopic Dermatitis.

OBJECTIVE: Desonide hydrogel 0.05%, an effective treatment for mild-to-moderate atopic dermatitis, is United States Food and Drug Administration approved as a treatment for patients as young as three months of age. Previous studies have also demonstrated that this hydrogel formulation of desonide 0.05% improved moisturization and reduced transepidermal water loss. Increased skin hydration has been correlated with improved and sustained integrity of the epidermal barrier in patients with atopic dermatitis. The objective of this clinical noninferiority study was to compare the efficacy of desonide hydrogel 0.05% with desonide ointment 0.05%, the clinical standard for the treatment of mild-to-moderate atopic dermatitis. DESIGN AND SETTING: Randomized, investigator-blinded, parallel-group, noninferiority study in an outpatient setting. PARTICIPANTS: Individuals 12 years of age and older with atopic dermatitis. MEASUREMENTS: Outcome measures included disease severity, body surface area involvement, subjective assessments of symptoms, corneometry, transepidermal water loss, and the patient's preference for vehicle attributes. Patients were assessed at Baseline, Week 2, and Week 4. RESULTS: Desonide hydrogel 0.05% was shown, through visual grading assessments and noninvasive instrumentation measurements, to be as effective as generic desonide ointment 0.05% in reducing the signs and symptoms of mild-to-moderate atopic dermatitis in patients aged 12 to 65 years during a four-week period. In addition, patients rated desonide hydrogel significantly better than desonide ointment for absorbability and (lack of) greasiness. CONCLUSION: Desonide hydrogel, which uses a hydrogel vehicle, was preferred by patients and shown to restore the skin barrier, thus offering an efficacious alternative to desonide ointment.

The importance of vehicle properties to patients with atopic dermatitis.

The properties of vehicle formulations may influence drug delivery, efficacy, and tolerance profiles of topical medications. Patient preferences vary and the importance of certain aesthetic attributes depend on the disease state, the site of application, and the length and extent of treatment, among other factors. Formulations that offer aesthetic advantages over traditional vehicles may improve patients' willingness to apply therapy as directed and therefore may affect the outcome of treatment. A participant preference study was conducted to determine if an aqueous gel (hydrogel) formulation of desonide would appeal to patients with atopic dermatitis (AD). Before treatment adult participants with AD completed a questionnaire to assess their AD history and prior topical treatments and to rate the importance of topical vehicle attributes. Each participant then applied desonide hydrogel 0.05% to affected areas twice daily for 4 weeks. At the end of the treatment, participants were queried on the attributes of desonide hydrogel and how it compared with other vehicles previously used. Twenty-two participants with mild to moderate AD completed the study; 100% (22/22) of participants found desonide hydrogel to be easy to apply/use/spread, easy to use on hair-bearing skin, comfortable to use under makeup and/or cosmetics, suitable for use on multiple body areas, and stain free. Most participants reported that the product was soothing (82% [18/22]), did not dry the skin (96% [21/22]), disappeared quickly (82% [18/22]), was comfortable to wear under clothes (91% [20/22]), and was not greasy or shiny on skin (96% [21/22]).

Moisturizing advantages of desonide hydrogel in treating atopic dermatitis.

The stratum corneum typically is compromised in patients with atopic dermatitis (AD). Beneficial AD treatments should provide moisture to the skin as well as restore impaired barrier function. Traditional treatments involve ointments or creams. A clinical study was conducted to determine if desonide in a hydrogel vehicle (HGV) could improve the moisture content and barrier function of the stratum corneum in adults with mild to moderate AD. Participants applied desonide hydrogel 0.05% twice daily for 4 weeks to areas of both lesional and nonlesional skin. Corneometry and transepidermal water loss (TEWL) were measured at baseline and weeks 1, 2, and 4. Statistically significant improvements in corneometry and TEWL measurements on lesional skin were observed at all study visits compared with baseline (all P < or = .002 and P < or = .04, respectively).

Enhanced efficacy of a facial hydrating serum in subjects with normal or self-perceived dry skin.

OBJECTIVE: To evaluate the efficacy and tolerance of a facial hydrating serum when added to a moisturizer regimen compared to a moisturizer regimen alone. DESIGN: Evaluator-blinded, single-center, clinical study with investigator assessments at Baseline and Week 2. TREATMENT: After washing with a facial cleanser in the morning and evening, subjects either applied the hydrating serum to their face followed by application of the moisturizer or applied only a moisturizer. PARTICIPANTS: Thirty-two women, aged 25 to 55 years with Fitzpatrick skin types I to V and normal or self-perceived dry skin completed the study. Seventeen subjects (Group 1) aged 25 to 51 years were randomly assigned to receive the facial hydrating serum in addition to a moisturizer regimen, whereas 15 subjects (Group 2) aged 34 to 55 years, were randomized to receive the moisturizer regimen alone. MEASUREMENTS: Visual grading of the condition of the facial skin with regard to dryness, tactile roughness and softness, rating of irritation (subjective and objective), and digital photography. A self-assessment questionnaire was also employed to assess patient satisfaction. RESULTS: Clinical assessments by the investigator showed statistically significant improvements (P<0.02) in facial skin parameters (reduction in dryness and increased skin softness) after two weeks of combined use of the hydrating serum and moisturizer compared to the group who used moisturizer alone. No adverse events were reported during the course of the study. CONCLUSION: The results from a two-week clinical study demonstrate that this facial hydrating serum was well tolerated and effective in improving facial dry skin parameters beyond that obtained with a moisturizer alone.

Irritation and allergy patch test analysis of topical treatments commonly used in wound care: evaluation on normal and compromised skin.

BACKGROUND: Topical agents indicated for the treatment of superficial wounds have the potential to cause irritation or allergic contact dermatitis, particularly when applied to an impaired skin barrier. OBJECTIVE: We sought to compare the irritancy potential of 5 topical wound care products commonly used in dermatologic practice on normal and compromised skin. METHODS: Agents tested included Aquaphor Healing Ointment (AHO) (Beiersdorf Inc, Wilton, CT); bacitracin; Biafine Topical Emulsion (BTE) (OrthoNeutrogena, Los Angeles, CA); Neosporin (Poly/Bac/Neo) (Johnson & Johnson, New Brunswick, NJ); and Polysporin (Poly/Bac) (Johnson & Johnson). Study 1 assessed cumulative irritation using a modified human repeat insult patch test on normal back skin with an induction phase (test materials applied under occlusive patch 9 times at 48- to 72-hour intervals) and a challenge phase (test materials applied to original and naïve sites for 48 hours, 12-24 days postinduction). Irritation was graded for erythema and type IV allergy skin responses. Study 2 assessed the acute irritation potential of agents on tape-stripped ("wounded") back skin. Test sites were graded for erythema, transepidermal water loss, and skin color (Chroma Meter a∗) (Minolta, Osaka, Japan) at 48 and 72 hours poststripping. RESULTS: In study 1, cumulative irritation testing in 108 subjects classified AHO, bacitracin, Poly/Bac/Neo, and Poly/Bac as "mild," and BTE as "probably mild." In study 2 at 72 hours, mean clinical grading scores were significantly higher for BTE and Poly/Bac/Neo than AHO. Transepidermal water loss and colorimeter a∗ values were significantly lower for AHO and bacitracin compared with BTE. No allergic contact dermatitis was seen in either study. CONCLUSIONS: Patch test studies demonstrated that BTE showed the greatest irritancy potential in both normal and compromised skin whereas AHO showed the least.

A comparison of postprocedural wound care treatments: do antibiotic-based ointments improve outcomes?

BACKGROUND: Topical antibiotic ointments are commonly used for the postprocedural treatment of superficial wounds created during dermatologic procedures. We propose that antibiotics may not be necessary for healing these wounds, have the potential to cause allergic contact dermatitis, and may contribute to the development of antibiotic resistance. OBJECTIVE: We sought to compare the efficacy and safety of a nonantibiotic, petrolatum-based ointment (Aquaphor Healing Ointment [AHO], Beiersdorf Inc, Wilton, CT) and an antibiotic-based first-aid ointment (Polysporin [Poly/Bac], Johnson & Johnson, New Brunswick, NJ) for the treatment of wounds created by removal of seborrheic keratoses. METHODS: In this double-blind study, 30 subjects each had two seborrheic keratoses removed from their trunk or abdomen; one wound was treated with AHO and one with Poly/Bac twice daily. Clinical grading of wound healing and subjective irritation was assessed at days 7, 14, and 28 postwounding. Adverse events were recorded. RESULTS: Clinical grading assessment showed no differences between wounds treated with AHO versus Poly/Bac for erythema, edema, epithelial confluence, crusting, and scabbing at any time point. Subjective irritation assessment showed wounds treated with Poly/Bac had a significant increase in burning at week 1, whereas no differences were seen between treatments for stinging, itching, tightness, tingling, or pain. One case of allergic contact dermatitis was reported after Poly/Bac treatment. LIMITATIONS: This was a relatively small study. CONCLUSIONS: This study demonstrated that the petrolatum-based skin protectant ointment AHO provided equivalent efficacy for wound healing as a combination antibiotic first-aid ointment. Antibiotics may not be necessary to achieve satisfactory wound healing and may cause allergic contact dermatitis.

Treatment of minor wounds from dermatologic procedures: a comparison of three topical wound care ointments using a laser wound model.

BACKGROUND: Topical antibiotic ointments are commonly used for postoperative wound care after dermatologic procedures such as curettage, electrodessication, or shave removals. Antibiotics have the potential to cause allergic contact dermatitis and increase drug resistance and may not be necessary for the treatment of clean surgical wounds. OBJECTIVE: This study compared the wound healing properties of the topical wound care ointments Aquaphor Healing Ointment (AHO) (Beiersdorf Inc, Wilton, CT), Neosporin (Poly/Bac/Neo) (Johnson & Johnson, New Brunswick, NJ), and Polysporin (Poly/Bac) (Johnson & Johnson) using a laser wound model. METHODS: In this double-blind study, 4 uniform circular erbium/carbon dioxide laser wounds penetrating to the dermis were made in 20 subjects. Each wound was treated 3 times daily for 18 days with AHO, Poly/Bac/Neo, or Poly/Bac, with one wound left untreated (control). Efficacy and safety were assessed using clinical grading, transepidermal water loss, investigator grading of wound appearance, subjective ranking of wound appearance, and adverse event reporting. RESULTS: Significant improvements in erythema (days 7-18), edema (days 4 and 7), epithelial confluence (days 7-18), and general wound appearance (days 7-18) were observed with AHO compared with Poly/Bac/Neo and Poly/Bac (P ≤ .007). No differences were observed between Poly/Bac/Neo and Poly/Bac for any clinical parameters. The average transepidermal water loss value on day 4 was significantly less with AHO compared with the other treatments (P = .0006). Subjects ranked the treated sites as follows: AHO (best), Poly/Bac, and Poly/Bac/Neo. No adverse events were reported. LIMITATIONS: This was a small pilot study using a laser wound model to replicate minor wounds. CONCLUSIONS: AHO demonstrated fast and effective improvements in several wound healing parameters compared with antibiotic-containing treatments.

Combination of physiologically balanced growth factors with antioxidants for reversal of facial photodamage.

A 3-month, open-label, single-center study was conducted to determine whether a uniquely formulated and physiologically balanced topical treatment serum containing multiple growth factors, cytokines, peptides, antioxidants and depigmenting agents could improve the visible signs of facial photodamage. Thirty-seven females, aged 32-55 years, with mild to severe, fine and coarse peri-ocular wrinkles were enrolled and completed the study. Subjects applied the treatment serum to the face twice daily for 3 months in conjunction with a basic skincare regimen. Clinical evaluations of photodamage were performed at baseline and months 1, 2 and 3. Cutometer measurements and subject self-assessment questionnaires were also conducted during the study. Clinical evaluations showed statistically significant reductions in fine wrinkles and coarse wrinkles and improvements in skin texture, tone and radiance starting at month 1 with continued improvements at months 2 and 3. Cutometer readings showed decreased skin extensibility and increased resiliency. Subject self-assessments confirmed that the beneficial effects of the treatment serum were readily observed by the users. The treatment serum was well-tolerated with no treatment-related adverse events reported during the 3-month study. Use of this novel treatment serum produced significant improvements in the visible signs of facial photodamage.

Clinical assessment of a combination lip treatment to restore moisturization and fullness.

Objective. To evaluate the efficacy and tolerance of a topical lip-care treatment. Step one of the two-step treatment is a lip-renewal formulation containing human growth factors, hyaluronic acid and marine filling spheres, emollients, and a tripeptide palmitoyl-glycyl-histidyl-lysine complex. Step two is a lip-plumper formulation containing niacin, emollients, and essential fatty acids. Design. Four-week, single-center, open-label, clinical study with clinical assessments at Baseline, Week 2, and Week 4. Treatment. Subjects wore the lip products at least eight hours every day with a minimum of three applications per day. Participants. Thirty-two women ages 22 to 40 years with mild-to-moderate lip dryness and average size lips completed the study. Measurements. Visual grading of the condition of the lips, rating of subjective irritation, corneometry, digital caliper measurements of lower lip, and digital photography. A self-assessment questionnaire was also employed to assess patient satisfaction. Results. Clinical assessments showed statistically significant improvements (P<0.001) in key lip condition parameters after both two and four weeks of use. Key parameters included lip scaling, cupping, cracking/fissuring, fine lines due to dryness, lip texture/visual roughness, lip color/rosiness, lip definition/contour, and overall lip condition. Significant increases (P<0.001) were observed in both corneometer measurements, which confirm the moisturizing benefits, and in digital caliper measurements, which confirm the lip-plumping benefits. Self-assessment questionnaires showed a 97-percent overall satisfaction rating. No adverse events were reported during the course of the study. Conclusion. The results from this clinical study demonstrate that this two-part lip-care treatment product was well tolerated and effective in restoring moisture and fullness to the lips of female subjects with mild-to-moderate lip dryness.

Immediate and Long-term Clinical Benefits of a Topical Treatment for Facial Lines and Wrinkles.

OBJECTIVE: To evaluate the efficacy and tolerance of a novel line treatment for periocular and perioral wrinkles. The line treatment was formulated with multiple growth factors, antioxidants, and a collagen-building peptide-ingredients that have been shown to increase collagen levels and provide long-term aesthetic benefits. To help provide immediate smoothing effects, hyaluronic acid filling spheres and a muscle contraction-inhibiting peptide were also included in the formulation. DESIGN: Three-month, single-center, open-label, clinical study with clinical assessments at Baseline, Minutes (within 15 minutes of initial application), Month 1, and Month 3. TREATMENT: Subjects treated periocular and perioral wrinkles twice daily for three months with the line treatment. PARTICIPANTS: Thirty-seven females, 33 to 45 years of age, with mild-to-moderate, fine and coarse periocular and perioral wrinkles, were enrolled in the study. MEASUREMENTS: Investigator assessments of fine and coarse periocular and perioral wrinkles, digital photography, and tolerance assessments were conducted at all visits. Subject self-assessment questionnaires were conducted within 15 minutes of initial application and at Month 3. RESULTS: Investigator assessments of both periocular and perioral wrinkles showed statistically significant improvements over Baseline within minutes of initial application; these positive findings continued to improve through Months 1 and 3 (all P