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Adapalene gel 0.1% in the treatment of infantile acne: an open clinical study.
Pediatr Dermatol. 2008 May-Jun; 25(3): 383-6
Kose O, Koç E, Arca E
Infantile acne is an uncommon condition in pediatric age. We determined the efficacy and safety of adapalene gel 0.1% in the treatment of infantile acne. Twelve patients were enrolled for adapalene gel 0.1% application once daily over a 16-week treatment period. Efficacy evaluation included counting the inflammatory and noninflammatory lesions by the physician and global evaluation of the improvement. After 16 weeks all patients were followed up for a 1-year period. The time of clearance of the infantile acne lesions was 3 months in four (33%) patients and 4 months in eight (67%) patients (median 3.4 months). Adapalene gel produced reductions in noninflammatory and inflammatory lesions counts. Limited side effects were observed and none of them required stopping the therapy. No patient was left with scarring. Three patients were showed mild lesions in the 1-year follow-up period. Adapalene gel 0.1% was found to be a highly effective and safe drug in the treatment of mild-to-moderate infantile acne.
Long-term safety and efficacy study of adapalene 0.3% gel.
J Drugs Dermatol. 2008 Jun; 7(6 Suppl): s24-8
Weiss JS, Thiboutot DM, Hwa J, Liu Y, Graeber M
The efficacy and safety of adapalene 0.1% gel in the treatment of acne vulgaris has been demonstrated in multiple controlled clinical trials. A higher concentration formulation, adapalene 0.3% gel, has been developed to provide a broader range of treatment options for acne management. Phase 3 clinical studies have demonstrated the superior efficacy of adapalene 0.3% gel compared to adapalene 0.1% gel and its vehicle at the end of a 12-week treatment period. The goal of this study was to evaluate the long-term safety of adapalene 0.3% gel in subjects treated once daily for 52 weeks, with a secondary objective to evaluate long-term efficacy. Subjects 12 years of age or older (N=551) with acne vulgaris participated in a multicenter, open-label study of the long-term (up to 52 weeks) efficacy and safety of once-daily applications of adapalene 0.3% gel. Of those enrolled, 167 subjects completed 12 months of treatment. Expected signs and symptoms of local cutaneous irritation (erythema, dryness, scaling, and stinging/burning) were mostly mild or moderate, with mean tolerability scores below 1 (mild) at all time points for the parameters assessed. Treatment-related, dermatologic adverse events were experienced by 21% of subjects and dry skin, skin discomfort, and scaling were reported by 10.5%, 8.3% and 3.3% of subjects, respectively. Most of the adverse events reported occurred in the first quarter of treatment. Adverse events were mostly mild to moderate in severity. Subjects treated with adapalene 0.3% gel for 52 weeks achieved a >75% median reduction in total, inflammatory, and noninflammatory lesions in this open-label study by the end of the treatment period. Adapalene 0.3% gel was safe and effective in the long-term (up to 1 year) treatment of subjects with acne vulgaris.
Adapalene 0.1% gel compared to tazarotene 0.1% cream in the treatment of acne vulgaris.
J Drugs Dermatol. 2008 Jun; 7(6 Suppl): s18-23
Pariser D, Colón LE, Johnson LA, Gottschalk RW
A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the appropriate treatment depends not only on efficacy but also on how well the patient can tolerate different formulations. The goal of this study was to evaluate the efficacy and tolerability of daily adapalene 0.1% gel compared to daily tazarotene 0.1% cream and to demonstrate the noninferiority of adapalene 0.1% gel when compared to tazarotene 0.1% cream in treating acne. This represents 2 arms of a 3-arm study. Subjects 12 to 35 years of age with acne vulgaris (N=202) participated in a 12-week, randomized, evaluator-blinded study of once-daily therapy with adapalene 0.1% gel versus tazarotene 0.1% cream. The primary measure of efficacy was the reduction in total lesion counts posttreatment. Subjects treated with adapalene 0.1% gel achieved similar reductions in total lesion counts at week 12 compared to the subjects treated with the tazarotene cream, which demonstrates the noninferiority of adapalene treatment compared to tazarotene (median difference: -1.18%; lower confidence limit [LCL]: -9.26). At week 2, the number of patients that experienced erythema and scaling with tazarotene 0.1% cream was greater when compared to adapalene 0.1% gel and statistically significant. By week 12, the percentage of subjects reporting cutaneous irritation had returned to or near baseline levels and was similar between treatment arms for all parameters assessed. Adapalene gel was associated with fewer treatment-related adverse events than tazarotene cream (36% versus 58%, respectively), and less than half as many adverse events that were "definitely" related to study treatment than tazarotene cream (20% versus 45%, respectively). Daily therapy with adapalene 0.1% gel was shown to be noninferior to tazarotene 0.1% cream in total acne lesion reductions, and during initial stages of treatment, demonstrated better tolerability with respect to erythema and scaling.
Is switching retinoids a sound strategy for the treatment of acne vulgaris?
J Drugs Dermatol. 2008 Jun; 7(6 Suppl): s11-7
Gold LS, Colón LE, Johnson LA, Gottschalk RW
Topical retinoids, such as adapalene gel and tazarotene cream, are considered first-line therapy for the treatment of acne vulgaris. Dermatologists often initiate adapalene gel treatment first, due to its good tolerability, followed by a switch to tazarotene cream in an effort to improve or hasten efficacy outcomes. The goal of this study was to compare the efficacy and safety of 2 daily regimens for the treatment of acne: adapalene 0.1% gel for 12 weeks and adapalene 0.1% gel for 6 weeks followed by tazarotene 0.1% cream for 6 weeks. The primary efficacy outcome was the percent of reduction in total lesion counts posttreatment. Subjects ages 12 to 35 years with acne vulgaris were selected to participate in a 12-week, randomized, evaluator-blind study of once-daily therapy with adapalene 0.1% gel (n=101) or "switch therapy," adapalene 0.1% gel followed by tazarotene 0.1% cream (n=100). Adapalene-treated subjects achieved similar percent reductions in total lesion counts at week 12 compared to subjects receiving switch therapy, demonstrating the noninferiority of adapalene gel treatment (median difference: -3.57%; lower confidence limit [LCL]: -11.25). Adapalene gel was associated with fewer reports of cutaneous irritation, particularly for scaling and stinging/burning, and fewer treatment-related adverse events compared to switch therapy. The results of this study indicate that daily therapy with adapalene 0.1% gel for 12 weeks was noninferior to switch therapy.
J Drugs Dermatol. 2008 Jun; 7(6 Suppl): s3-10
Thiboutot D, Arsonnaud S, Soto P
Treatment of acne vulgaris can be challenging for both patients and physicians. Topical retinoids are often considered first-line therapy for the treatment of all but the most severe forms of acne. A variety of formulations of topical retinoids, including adapalene and tazarotene, are available but tazarotene 0.1% gel is widely perceived to be the most efficacious. The goal of this study was to evaluate the efficacy and tolerability of a new, higher concentration of adapalene, adapalene 0.3% gel, compared to tazarotene 0.1% gel in the treatment of acne vulgaris. The primary efficacy outcome was the percent reduction in total lesion count at week 12. Subjects 12 to 35 years of age with acne vulgaris (N=172) participated in a 12-week, randomized, evaluator-blinded, noninferiority study of once-daily therapy with adapalene 0.3% gel or tazarotene 0.1% gel. Subjects in each group achieved clinically significant reductions in total lesion counts at week 12 (61% and 57% median reductions for adapalene and tazarotene, respectively); adapalene 0.3% gel was noninferior to tazarotene 0.1% gel (95% confidence interval [CI]: -5.2-9.6). The adapalene arm was also therapeutically similar to the tazarotene arm in terms of the percent reduction in inflammatory and noninflammatory lesion counts at week 12, as well as in the assessments of acne severity and improvement. Mean tolerability scores for erythema, dryness, scaling, and stinging/burning were consistently lower in the adapalene arm compared to patients treated with tazarotene (P
J Drugs Dermatol. 2008 Jun; 7(6 Suppl): s2
Del Rosso JQ
Intracranial hypertension in a patient using topical adapalene.
J Neuroophthalmol. 2008 Jun; 28(2): 156-8
Givre SJ, Fleischman D
Topical retinoids in acne - an evidence-based overview.
J Dtsch Dermatol Ges. 2008 May 13;
Thielitz A, Naser MB, Fluhr JW, Zouboulis CC, Gollnick H
Topical retinoids are important tools in the management of acne because they act against comedones and microcomedones and have direct anti-inflammatory effects. The substances approved for acne treatment comprise tretinoin (all-trans-retinoic acid),isotretinoin (13-cis retinoic acid) as well as the synthetic third-generation polyaromatic retinoids adapalene and tazarotene,the latter being approved for acne treatment in the US only.Retinaldehyde is used in cosmetic preparations against acne. All topical retinoids are effective as single agents in mild to moderate acne but differ in efficacy and tolerability. Tazarotene 0.1% is more effective than tretinoin 0.025% or 0.1% microsphere gel or adapalene 0.1% gel or cream (EBM-level 2c). Adapalene 0.1% is equally effective to tretinoin 0.025% or tretinoin microsphere 0.1% gel or tretinoin 0.05% cream or isotretinoin 0.05% gel (EBM-level 2c). Adapalene 0.1% gel is significantly better tolerated than tazarotene 0.1% gel, tretinoin 0.025% and tretinoin 0.05% gel, tretinoin 0.05% cream,tretinoin microsphere 0.1% gel or isotretinoin 0.05% gel (EBM-level 2c).The safety profile of topical retinoids differs from their systemic counterparts and is related mainly to local adverse effects, such as erythema, dry-ness,itching and stinging.The currently available evidence justifies the use of topical retinoids in most types of acne and during maintenance treatment.
A review of the use of adapalene for the treatment of acne vulgaris.
Ther Clin Risk Manag. 2007 Aug; 3(4): 621-4
Piskin S, Uzunali E
Acne is a disease of the pilosebaceous unit with involving abnormalities in sebum production, microbial flora changes, abnormal keratinization, and inflammation. There are several therapeutic options like topical and systemic retinoids, antibiotics, and systemic hormonal drugs. The topical retinoids a play very important role in the treatment of acne vulgaris. However, their use is limited due to skin irritation. A new generation product, adapalene is a good choice in the treatment of acne vulgaris with less side effects and high efficacy confirmed by numerous clinical studies.
Cutis. 2008 Mar; 81(3): 278-84
Andres P, Pernin C, Poncet M
Combination therapy is an effective approach to simultaneously target multiple pathogenic factors of acne. International consensus guidelines recommend the use of topical retinoids and benzoyl peroxide (BPO) for acne treatment. These drugs are often prescribed as a free combination without any safety concern associated with antibiotic use. A 3-week, randomized, controlled, investigator-blinded, single-center, bilateral (split-face), dose-assessment study was conducted comparing the cutaneous tolerability of 2 adapalene-BPO fixed-dose combination products versus various concentrations of BPO monotherapy applied once daily. Sixty healthy participants were randomized to one of the following treatment groups: adapalene 0.1%-BPO 2.5% combination product versus BPO 2.5% monotherapy; adapalene 0.1%-BPO 2.5% combination product versus BPO 5% monotherapy; adapalene 0.1%-BPO 5% combination product versus BPO 5% monotherapy; and adapalene 0.1%-BPO 5% combination product versus BPO 10% monotherapy. Assessments included total sum score (TSS) of irritation signs/ symptoms (erythema, scaling/desquamation, dryness, pruritus, stinging/burning) averaged over all postbaseline visits, individual irritation signs/symptoms (worst score), and adverse events. The overall cutaneous tolerability profile of the adapalene 0.1%-BPO 2.5% combination product was better than the combination with BPO 5% and similar to BPO 2.5% or 5% monotherapy. The combination product with BPO 5% induced significantly more irritation than BPO 5% monotherapy (P < .001) or BPO 10% monotherapy (P = .001). In conclusion, the new fixed-dose adapalene 0.1%-BPO 2.5% combination product provided the best overall cutaneous tolerability profile relative to BPO monotherapy.