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Background: Acne is a chronic inflammatory disease of the pilosebaceous units. It is characterized by seborrhea, the formation of open and closed comedones, erythematous papules, and pustules and in more severe cases nodules, deep pustules, and pseudocysts. In many cases, a degree of scarring will ensues. Four major factors involved in pathogenesis are as follows: (i) Increased sebum production, (ii) hypercornification of the pilosebaceous duct, (iii) abnormality of the microbial flora, especially colonization of the duct with propionibacterium acnes, and (iv) inflammation. Aim and Objectives: The aims of the study were as follows: (1). Comparison of success rate among the patients receiving benzoyl peroxide 2.5% and adapalene 0.1% in patients diagnosed with mild-to-moderate acne vulgaris. (2). To compare the decrease lesion count. Materials and Methods: After obtaining approval from the Institutional Ethics Committee, the patients for the study were enrolled from the Department of Dermatology Venereology and Leprosy, Osmania General Hospital, Hyderabad. Patients diagnosed with mild-to-moderate acne vulgaris according to Global Acne Grading system were included in the study. A total of 100 patients were divided into two groups (Group A and Group B). Each group consists of 50 patients each. Group A received: Topical benzoyl peroxide 2.5% gel for 12 weeks. Group B received: Topical adapalene 0.1% gel for 12 weeks. Follow-up was done at 3, 6, 9, and 12 weeks of treatment. Acne scores were recorded at baseline and at, 3, 6, 9, and 12 weeks of treatment. The global acne grading score (GAGS) was used for assessing the severity of acne at each visit. Results: All the data were entered in a Microsoft Excel sheet and analysis was done using Graph prism version 7. Continuous data were expressed in terms of mean and standard deviation. Comparison of acne scores in each group before and after treatment at each follow-up visit was performed using Student t-test. Comparison of acne scores among the two groups was performed at baseline and at the end of 12 weeks by unpaired t-test. A detailed history was recorded and clinical examination was done. Acne grading was done using the GAGS. Conclusion: There was significant decrease in mean acne scores. Decrease in mean acne scores of Group A (benzoyl peroxide 2.5% gel) was compared with that of Group B (adapalene 0.1% gel) using unpaired t-test. There was no significant difference in between benzoyl peroxide and adapalene on mean acne scores. It was found that both the treatment groups were effective in reducing acne score.
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Background: Topical adapalene and tretinoin, are comedolytic, anti-comedogenic and anti-inflammatory, on RAR (?, ?, ?) receptors binding. Adapalene enables quicker follicular penetration, by lesser anti-AP-1 (c-Jun, c-Fos) and no CRBPII mRNA actions, causing chemical stability, lipophilicity and less photo-lability, producing lesser photosensitivity and no skin irritation, unlike tretinoin; wherein reducible by overnight application and combination therapy, slow-release polymers or emollients, respectively. Topical nadifloxacin is bactericidal, anti-inflammatory and comedolytic, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1?, IL-6, IL-8. The Global Alliance to Improve Outcomes in Acne Guidelines recommend synergistic and additive combination therapies, which enhance therapeutic efficacy and reduce adverse effects. Due to inadequacy of data, this study was conducted, to compare the safety among topical anti-acne monotherapies and combination therapies, and to easily detect any adverse effect producing component in the topical combination therapy.Methods: In this multi-centre, prospective, randomised, open-labelled, comparative study, groups A, B, C, D and E (20 patients each), applied topical 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, respectively, over their facial mild to moderate acne lesions, once daily overnight; and adverse effects, like erythema, scaling, dryness, prutitus, burning, or stinging, were assessed on 0, 15, 30, 60, 90 days and follow-ups, by Local Irritation Scale.Results: In all 5 groups, no adverse effects were observed, with no statistically significant difference among the observations.Conclusions: The therapies were well tolerated and safe among all 5 groups.
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Objective To prepare, investigate and optimize the drug stability of compound adapalene ointment.Methods The ointment containing adapalene and mupirocin were prepared with PEG400and PEG3350as matrix.Stress test was usedto evaluate and optimize the stability of drugs in the ointment.The drug stability was further tested by the acceleration test and long-term test.Results The raw adapalene was stable under high temperature, high humidity and strong light irradiation.The raw mupirocin was stable under high humidity and strong light irradiation, but was highly unstable under high temperature condition.Degradation of adapalene and mupirocin was found with pH≤7.At pH 7.5, the best stability was achieved, with over95％of the drugs remaining at day 10.Favorable ointment was prepared with PEG400∶PEG3350=2∶1.The drug stability was promoted by addition of 0.2％triethanolamine significantly.In the acceleration test and long-term test, the percentages of adapalene and mupirocin were above 95％.Conclusion The compound adapalene ointment was successfully prepared and the drug stability was excellent.
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Objective To investigate effect of BCG polyose nuclear acid combined with adapalene Gel in the treatment of flat wart.MethodsFrom January 2015 to May 2016, 100 flat wart patients were selected in our hospital, the patients were divided into observation group and control group, each group 50 cases, the control group was given Adapalene Gel therapy, the treatment group was treated with BCG polyose nuclear acid on the basis of control group, the therapeutic effect of the two groups were observed.ResultsThe total effective rate of the treatment group was 84.0%(42/50), and the control group was 60.0%(30/50)The treatment effect of observation group was significantly better than the control group (P< 0.05);The skin lesion score of observation group after treatment was (4.22±1.05) scores, which was significantly lower than that in the control group (P< 0.05);There was no significant difference in T lymphocyte subsets between the observation group and the control group;After treatment, the lgG and lgM in observationgroup were higher than before treatment (P< 0.05);The adverse reaction rates of the observation group and the control group were 14.0%(7/50) and 18.0%(9/50), the difference was not statistically significant.ConclusionThe therapeutic effect of BCG polyose nuclear acid combined with adapalene gel in the treatment of flat wart is better, it can improve the humoral immune function of patients, and it is safe and reliable.
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BACKGROUND: The efficacy and safety of daily maintenance treatment with an adapalene-benzoyl peroxide (adapalene-BPO) fixed-dose combination gel is established in acne vulgaris in adults. OBJECTIVE: This study evaluated the efficacy and tolerability of twice-per-week maintenance therapy with an adapalene-BPO combination gel for acne vulgaris in adults. METHODS: All patients applied the adapalene-BPO combination gel once daily during the initial 8 weeks. Subsequently, the patients were randomized into two groups. The maintenance group applied the ointment twice-per-week for 12 weeks of maintenance treatment, while the control group discontinued treatment after the initial 8 weeks active treatment. The changes in the mean numbers of total, inflammatory, and non-inflammatory lesions were assessed. RESULTS: During maintenance treatment, the changes in the average numbers of total and inflammatory lesions in the maintenance group differed significantly from the control group. CONCLUSION: Twice-per-week application of an adapalene-BPO combination gel after active treatment appears to be a good option for the maintenance therapy of acne vulgaris in adults.
Subject(s)
Adult , Humans , Acne Vulgaris , Benzoyl Peroxide , AdapaleneABSTRACT
Topical application of Isotretinoin and Adapalene has proved effective in treating acne vulgaris. Both drugs demonstrate therapeutic advantages and less irritancy over tretinoin, the most widely used treatment for acne. The objective of this study was to compare the efficacy and tolerability of Adapalene cream 0.1% and Isotretinoin cream 0·05% in the treatment of acne vulgaris. Hundred patients were enrolled and were instructed to apply Adapalene cream 0.1% (50 patients) or Isotretinoin cream 0.05% (50 patients) once daily over a 6-week treatment period. Efficacy determination included non-inflammatory and inflammatory lesions count by the investigator and global evaluation of improvement. Cutaneous tolerance was assessed by determining erythema, scaling, burning and pruritus. Adapalene and Isotretinoin creams were highly effective in treating acne vulgaris. However Adapalene was found significantly more effective than Isotretinoin. Adapalene has faster onset of action of, which reflects on patients psychologically in term of improvements, comforts and good appearance. Significantly lower skin irritation was noted with Adapalene , indicating that Adapalene may begin a new era of treatment with low-irritant retinoids. It seems that, Adapalene treatment is a good choice for topical treatment of acne vulgaris with less side effects and high efficacy. Adapalene should be described as first line for treatment of acne vulgaris.
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BACKGROUND: While adapalene and benzoyl peroxide have both been demonstrated to be effective for the treatment of acne vulgaris, they can also cause skin irritation, resulting in patient incompliance. In addition, the irritation may be severe when adapalene is co-administered with benzoyl peroxide. OBJECTIVE: The intention of this study was to evaluate the efficacy and safety of adapalene 0.1%-benzoyl peroxide 2.5% fixed-dose combination gel, and adapalene 0.1% gel monotherapy, for the treatment of mild to moderate acne. Any changes in the skin barrier function were also measured. METHODS: A total of 52 patients applied adapalene-benzoyl peroxide gel or adapalene gel once daily. The changes in lesion counts, investigator's global assessment, patient satisfaction, and adverse events were recorded for 6 weeks. The biophysical profiles of the skin, including transepidermal water loss and redness, were measured for 3 weeks. RESULTS: Both agents were effective for the treatment of acne lesions. Adapalene-benzoyl peroxide showed a faster onset of action than adapalene, especially on inflammatory lesions. However, at week 6, both agents showed a similar effect in reducing lesion counts. While most patients in both groups experienced skin irritation from week 1, this gradually reduced. Likewise, the changes in transepidermal water loss and redness showed peak rates at week 1 and 2, but decreased over time. CONCLUSION: Adapalene-benzoyl peroxide gel is effective for the treatment of acne with a safety profile comparable to adapalene gel. The skin irritation experienced may be associated with the changes in skin barrier disruption, which lasts for 1~2 weeks.
Subject(s)
Humans , Acne Vulgaris , Benzoyl Peroxide , Intention , Patient Satisfaction , Skin , AdapaleneABSTRACT
BACKGROUND: An antibiotic-free, fixed-dose combination gel with adapalene (A) 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for treatment of acne vulgaris. OBJECTIVE: To compare the clinical outcomes of A-BPO combination gel with vehicle gel for treatment or maintenance therapy of patients with acne vulgaris. METHODS: An electronic search of the database PubMed (1966 to September 2012), Embase (1984 to September 2012), and Cochrane Controlled Trials Register (CENTRAL; 3rd Quarter, 2012) was undertaken to identify relevant studies. Main clinical outcomes were success rate, treatment-related adverse events (AEs), AEs leading to discontinuation, satisfaction with the effectiveness, and overall satisfaction. RESULTS: Six studies were finally included in this meta-analysis. The A-BPO group yielded better clinical outcomes regarding the success rate (p<0.00001), satisfaction with the effectiveness of treatment (p=0.005), and overall satisfaction (p=0.005) compared to the vehicle group. The incidence of treatment-related AEs in the A-BPO group was comparable with that of vehicle group (p=0.09), while the A-BPO group was associated with a slightly increase in the incidence of AEs leading to discontinuation when compared with the vehicle group (p=0.02). CONCLUSION: A-BPO combination gel yields better clinical outcomes including success rate, satisfaction with the effectiveness, and overall satisfaction compared to vehicle gel, despite an increased incidence of AEs leading to discontinuation. The A-BPO combination agent most likely contributes to the treatment of moderate acne vulgaris rather than severe acne vulgaris, but it may be useful in maintenance therapy of patients with severe acne vulgaris.
Subject(s)
Humans , Acne Vulgaris , Benzoyl Peroxide , Incidence , AdapaleneABSTRACT
Objective To evaluate the combined treatment effect of intensive pulsed light (IPL,420 nm and 540 nm,by mode of 4+3) on acne vulgaris and acne erythem.Methods A total of 80 patients with acne vulgaris were divided randomly into the treatment and the control group.The treatment group including forty cases were first treated by 420 nm IPL for 4 times,and the interval was one week; and then treated by IPL 420 nm combined with 540 nm for 3 times,the interval was four weeks.The control group was just treated by Adapalene at every night for 16 weeks.Results The treatment efficiency of inflammatory lesion after 4 weeks showed that the effective rate in the treatment group was 65.0 ％ compared to 47.5 ％ in the control group,and the difference was statistically significant (P＜0.05).The treatment results of inflammatory lesion after 16 weeks showed that efficiency was 85％ in the treatment group,while 62.5％ in the control group,and difference was statistically significant (P＜0.05).The treatment results of acne erythem showed that the effective rate was 90 ％ in the treatment group,but 37.5 ％ in control group,there was statistically significant (P＜ 0.01) between the two groups.Conclusions Combined use of 420 nm and 540nm IPL by protocol of4+3 is an effective method for treatment of acne vulgaris and acne erythem.
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Background: Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients. Aims: To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial. Methods: Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate) 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant. Results: 209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients) and conventional gel (91/93 patients) groups. Significantly better reductions in total (79.7% vs. 62.7%), inflammatory (88.7% vs. 71.4%) and noninflammatory (74.9% vs. 58.4%) lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all). Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001) than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05) and erythema (0.8% vs. 9.9%; P < 0.05) were recorded with the nano-emulsion gel. Conclusions: The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation for the treatment of acne vulgaris in Indian patients. Further studies can elucidate the comparative treatment benefits of this nano-emulsion gel formulation.
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A simple, selective, precise and stability-indicating Isocratic high-performance chromatographic method of analysis for adapalene as a model lipophylic drug in Transdermal (gel) formulations was developed. Mobile phase consisted of acetonitrile(ACN), tetrahydrofuran (THF) and phosphate buffer (PB) (pH-2.5; 0.01 M) in the ratio of 30:40:30 respectively. This mobile phase was found to give adequate results in terms of peak shape, symmetry, tangent and tailing. Retention time (RT) for adapalene was found to be 2.4 with run time of 5 minutes. Samples were subjected to acid, alkali hydrolysis, oxidation, thermal, humidity and photodegradation. The whole analysis was carried out at the wavelength of 272 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9995 with respect to peak area in the concentration range of 14-26μg/ml.The mean value of correlation coefficient; slope and intercept were 0.9995, 9060.51 and 1282. The method was validated for precision, specificity, recovery and robustness, in accordance with ICH guidelines. The drug undergoes degradation under basic (alkaline) conditions. This indicates that the drug is susceptible to base hydrolysis. Statistical analysis proves that the method is reproducible, selective and accurate for the estimation of said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.
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BACKGROUND: A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for once-daily treatment of acne. It is known to be effective to reduce inflammatory and non-inflammatory lesions, but there have been no study in Korean yet. OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) for the treatment of mild to moderate severity acne in Korean. METHODS: In total, 64 patients with mild to moderate severity acne were enrolled. Adapalene-BPO was applied to face once daily at night. The efficacy assessment was performed at baseline and monthly for 3 months: inflammatory lesions (IL), non-inflammatory lesions (NIL), total lesions (TL) were counted and median percentage changes of each lesion were measured for 3 months with patient satisfaction and adverse events questionnaire. RESULTS: Of the 64 patients enrolled, 58 have completed 3-month treatments. Adapalene-BPO showed early onset of action with significant reduction in inflammatory, non-inflammatory, and total lesion counts. The median percentage reduction of mild group from baseline to 3rd month was greater than moderate group in IL, NIL, and TL counts (71.1% vs 65%/61.4% vs 56.4%/67.7% vs 62% reduction). Also, patient satisfaction score improved and significant reduction of Korea Acne Grading System (KAGS) was noted in both groups. All the reported adverse events were mild. CONCLUSION: This study shows that adapalene-BPO is an effective and safe treatment regimen for both mild and moderate acne. It has a better effect for treating mild severity acne than moderate acne with reduction of the IL, NIL, and TL counts and greater patient satisfaction.
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Humans , Acne Vulgaris , Benzoyl Peroxide , Korea , Naphthalenes , Patient Satisfaction , AdapaleneABSTRACT
Objective To summarize the experience with adapalene in the treatment of ache vulgaris and to provide a clue to improve the clinical use of adapalene in ache vulgaris. Methods Chinese literature over the past ten years related to the evaluation of efficacy and safety of 0.1% adapalene gel in acne vulgaris were searched and assessed. Results Combination therapy with 0.1% adapalene was more effective than monotherapy with it. The efficacy of adapalene gel was higher than that of non-tretinoin topical agents, but equivalent to that of other tretinoins. Furthermore, the incidence of adverse events was lower for adapalene than for other tretinoin formulations. Conclusions Adapalene is safe and effective for the treatment of mild to moderate acne vulgaris, and can be used as monotherapy, maintenance treatment, or in combination therapy of acne vulgaris.
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OBJECTIVE:To observe the clinical efficacy of Xinhuang tablets combined with Azithromycin granules and 0.1% Adapalene gel in the treatment of acne vulgaris.METHODS:216 patients with acne vulgaris were randomly divided into experimental group and control group according to visiting order (n=108).Experimental group were treated with oral administration of Xinhuang tablets and Azithromycin granules and 0.1% Adapalene gel for external use.Control group were treated with Erythromycin enteric-coated tablets and Compound sulfur lotion.Clinical efficacies of 2 groups were observed after 6 weeks.RESULTS:Total effective rate was 97.2% for experimental group and 41.6% for control group.There was significant difference between 2 groups (P
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Dariers disease is inherited as an autosomal dominant trait and characterized by follicular pruritic hyperkeratotic papules. The onset is usually in late childhood and the course of the disease is chronic and slowly progressive in most cases. Dariers disease is refractory to treatment with most conventional keratolytics and anti-inflammatory agents. To date, oral and topical retinoid products have been the mainstay therapy for this population, but local as well as systemic side effects often limit their effectiveness. We present a case of localized Dariers disease which responded promptly to the topical application of adapalene 0.1% gel without side effects. A review of treatment for Dariers disease also is presented.
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Anti-Inflammatory Agents , Darier Disease , AdapaleneABSTRACT
Objective To evaluate the clinical efficacy and safety of adapalene0.1%gel with individ-ualized treatment regimen for acne vulgaris(ITRAV).Methods Eighty-one patients with acne vulgaris of mild to moderate severity were treated with adapalene0.1%gel topically1to3times daily for6to8weeks according to the severity of the disease.Clinical responses were recorded and photographed weekly in30pa-tients randomly selected from the81patients,and treatment regimens were adjusted accordingly.Results It was shown that cure rates were44.4%and73.4%,in81recruited cases and30selected cases,respectively.Seborrhea decreased remarkably(83.3%)in the treatment.Side effects took place in39.5%of patients with-out interruption of the treatment.Conclusions ITRAV with adapalene0.1%gel has been proved to have an excellent response.Reasonably increasing the daily dosage could improve the cure rates.The cutaneous tolera-bility of the drug was generally good.Seborrhea could be reduced considerably during the treatment