Efficacy and tolerability of adapalene 0.3% gel compared to tazarotene 0.1% gel in the treatment of acne vulgaris.

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<.014 at week 12, Cochran-Mantel-Haenszel [CMH] test). The worst score for any tolerability parameter in the treatment phase in the adapalene arm was less than 1 (mild). Adapalene was also associated with a lower incidence of treatment-related adverse events when compared to tazarotene (3.5% versus 14%, respectively). Once daily therapy with adapalene 0.3% gel provided similar efficacy (noninferior) to tazarotene 0.1% gel in the treatment of acne vulgaris, but demonstrated a superior tolerability profile.

Tolerability comparison of adapalene gel, 0.3% versus tazarotene cream, 0.05% in subjects with healthy skin.

BACKGROUND: Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne. Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to be compared to other topical retinoids. PURPOSE: The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus tazarotene cream 0.05% once daily. METHODS: Subjects reported to the investigative site each day Monday through Friday, cleansed the faced and then applied adapalene 0.3% gel to one side of the face and tazarotene 0.05% cream to the other in the presence of study personnel. For the weekends, subjects were instructed to apply the treatment at home according to the same procedure. Tolerability was assessed during each weekday visit. The study lasted for 3 weeks. RESULTS: Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel. CONCLUSION: Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.

Cumulative irritancy comparison of topical retinoid and antimicrobial combination therapies.

BACKGROUND: The use of multiple topical drugs for the treatment of acne may cause elevated irritation. Therefore, the selection of a combination regimen should include a careful consideration of the irritation potential of the individual acne medications. OBJECTIVE AND METHODS: To compare the cumulative irritation potential of adapalene gel 0.1%, tazarotene cream 0.05%, and tretinoin microsphere 0.04% when applied in combination with two benzoyl peroxide/clindamycin topical gels in 35 healthy subjects in a 3-week, randomized, controlled study. RESULTS: The mean cumulative irritancy index of adapalene combinations was significantly lower relative to tretinoin and tazarotene regimens (all P<.01). Test areas exposed to tretinoin or tazarotene were also more likely to be discontinued for severe irritation than those exposed to adapalene. There were no serious adverse events. No significant difference in the irritancy potentials of tazarotene and tretinoin combination regimens was observed. CONCLUSIONS: Adapalene gel 0.1% has tolerability superior to both tazarotene cream 0.05% and tretinoin microsphere 0.04% when used in topical combination therapy. In view of the lower irritation potential observed in this study, along with its demonstrated efficacy, adapalene gel 0.1% in combination with antimicrobial agents may be used as part of an aggressive treatment regimen for the management of acne.

A randomized, investigator-masked clinical evaluation of the efficacy and safety of clobetasol propionate 0.05% shampoo and tar blend 1% shampoo in the treatment of moderate to severe scalp psoriasis.

The clinical benefit of currently available tar blend shampoos for the treatment of scalp psoriasis is restricted due to their limited efficacy, low cosmetic appeal and potential for carcinogenicity. This 4-week multicentre, randomized, parallel-group, investigator-masked study included 162 subjects and aimed to compare the efficacy, safety and cosmetic acceptability of clobetasol propionate 0.05% shampoo versus a currently marketed tar blend 1% shampoo in subjects with moderate to severe scalp psoriasis. Clobetasol propionate shampoo was superior to tar blend shampoo with respect to all efficacy variables tested (p<0.001): Total and Global Severity Score; erythema; plaque thickening; desquamation; pruritus; total scalp area involved; and the subject's global assessment of clinical improvement. Both treatments were safe and well-tolerated. Furthermore, more subjects indicated that clobetasol propionate shampoo was more cosmetically acceptable than tar blend shampoo. Clobetasol propionate 0.05% shampoo is a good alternative to tar blend shampoo in the treatment of moderate to severe scalp psoriasis.

Efficacy and safety of once-daily metronidazole 1% gel compared with twice-daily azelaic acid 15% gel in the treatment of rosacea.

Rosacea is an inflammatory dermatologic disorder characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. The National Rosacea Society has established a classification system that identifies 4 distinct rosacea subtypes based on clinical presentation: erythematotelangiectatic, papulopustular, phymatous, and ocular. The goal of topical therapy for rosacea is to reduce inflammatory lesion counts; decrease intensity of erythema; and reduce symptoms such as stinging, burning, and pruritus. Metronidazole and azelaic acid are thought to reduce the inflammation associated with rosacea by inhibiting the production of reactive oxygen species produced by neutrophils. Both metronidazole 1% gel and azelaic acid 15% gel recently have been approved for the treatment of rosacea. The current study was conducted to compare the once-daily application of metronidazole 1% gel with twice-daily applications of azelaic acid 15% gel for the treatment of patients with moderate rosacea (N=160). Both treatments showed similar reductions in inflammatory lesion counts (77% for metronidazole 1% gel and 80% for azelaic acid 15% gel) and high success rates in both global severity (53.7% vs 56.4% for metronidazole 1% gel and azelaic acid 15% gel, respectively) and erythema (42.7% vs 42.3% for metronidazole 1% gel and azelaic acid 15% gel, respectively). On average, the efficacy (including reduction in erythema) of the once-daily application of metronidazole 1% gel and twice-daily applications of azelaic acid 15% gel were similar.

Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study.

OBJECTIVE: To assess the maintenance effect of adapalene gel, 0.1%, relative to gel vehicle in subjects successfully treated in a previous 12-week study of adapalene-doxycycline, 100 mg, combination therapy. DESIGN: Multicenter, investigator-blind, randomized, controlled study. SETTING: Thirty-four US centers. SUBJECTS: A total of 253 subjects with severe acne vulgaris who showed at least moderate improvement from baseline (50% improvement from baseline) when treated with either adapalene plus doxycycline or doxycycline plus gel vehicle in a previous 12-week study. INTERVENTIONS: Subjects were randomized to receive adapalene gel, 0.1%, or gel vehicle once daily for 16 weeks. MAIN OUTCOME MEASURES: Efficacy and safety criteria included maintenance rate (subjects maintaining at least 50% improvement in lesion counts from previous therapy), lesion counts (total, inflammatory, and noninflammatory), global severity assessment, cutaneous tolerability, and adverse events. RESULTS: Adapalene maintenance therapy resulted in significantly larger maintenance rates (75% vs 54%; P<.001) and significantly lower lesion counts (total [P = .005], inflammatory [P = .01], and noninflammatory [P = .02]) compared with gel vehicle. Adapalene was safe and well tolerated in this study. Conclusion This study demonstrates a clinical benefit of continued treatment with adapalene gel, 0.1%, as a maintenance therapy for acne.

The Taylor Hyperpigmentation Scale: a new visual assessment tool for the evaluation of skin color and pigmentation.

The Taylor Hyperpigmentation Scale is a new visual scale developed to provide an inexpensive and convenient method to assess skin color and monitor the improvement of hyperpigmentation following therapy. The tool consists of 15 uniquely colored plastic cards spanning the full range of skin hues and is applicable to individuals with Fitzpatrick skin types I to VI. Each card contains 10 bands of increasingly darker gradations of skin hue that represent progressive levels of hyperpigmentation. This article describes the ongoing development of the Taylor Hyperpigmentation Scale and reports the results of a recent validation study of the use of this newly developed chart in individuals with skin of color. In the study, skin color and an area of hyperpigmentation in 30 subjects of white, African American, Asian, or Hispanic ancestry (approximately 5 from each of the 6 skin types) were evaluated by 10 investigators. The results of the study revealed significant variation among intraindividual and interindividual ratings by investigators of skin hue (P < .0001) and hyperpigmentation (P = .0008); however, most investigators rated the scale as useful and easy to use, and 60% stated they would use it in clinical practice to document the response of hyperpigmentation to therapeutic agents. A heuristic evaluation of the results of this study provided insight into essential considerations for the continued effort to develop a useful and simple scale for assessing skin color and pigmentation.

Cumulative irritation potential of adapalene 0.1% cream and gel compared with tazarotene cream 0.05% and 0.1%.

Despite the many beneficial effects of dermatologic applications, most of the current treatments for acne cause local irritation. The objective of this study was to compare the ability of the epidermis to tolerate adapalene 0.1% cream and gel and tazarotene cream in concentrations of 0.05% and 0.1%. A total of 30 subjects were enrolled in the study. The test products were applied under occlusive dressings at randomized sites on the upper back for approximately 24 hours, 4 times a week, and for 72 hours, once a week, for a period of 3 weeks. Skin reactions (erythema score plus other local reactions) at the product application sites were assessed 15 to 30 minutes after dressing removal. Twenty-six subjects completed the study. A total of 16 subjects discontinued use of 1 or more of the test products because of irritation scores reaching severe or greater; all but one of these discontinuations were at sites treated with the tazarotene products. The mean 21-day cumulative irritancy indices for adapalene 0.1% cream and gel were significantly lower (P=.05) than those for tazarotene cream 0.05% and 0.1% and not notably higher than that of the negative control product.

Cumulative irritation potential of adapalene 0.1% cream and gel compared with tretinoin microsphere 0.04% and 0.1%.

Despite the many beneficial effects of dermatologic applications, most of the current treatments for acne cause local irritation. The objective of this study was to compare the ability of the epidermis to tolerate adapalene 0.1% cream and gel and tretinoin microsphere in concentrations of 0.04% and 0.1%. A total of 31 subjects were enrolled in the study. The test products were applied under occlusive dressings on the upper back for approximately 24 hours, 4 times a week, and for 72 hours, once a week, for a period of 3 weeks. Skin reactions (erythema score plus other local reactions) at the product application sites were assessed 5 to 30 minutes after dressing removal. Twenty-six subjects completed the study. A total of 10 subjects discontinued use of 1 or more of the test products because of irritation scores reaching severe or greater, all of these discontinuations were at sites treated with the tretinoin products. The mean 21-day cumulative irritancy indices for adapalene 0. 1% cream and gel were significantly lower (P<.01) than those for tretirnoin microsphere 0.04% and 0. 1% and not higher than that of the negative control product.

Combination therapy with adapalene gel 0.1% and doxycycline for severe acne vulgaris: a multicenter, investigator-blind, randomized, controlled study.

BACKGROUND: Combination therapy with a topical retinoid and an antibiotic is recognized as a rational and effective approach for the treatment of acne vulgaris. Adapalene, a naphthoic acid derivative with anti-inflammatory and receptor-selective retinoid properties, is safe and well tolerated. While the combination of adapalene with oral or topical antibiotics has been shown to deliver a superior and faster response than an antibiotic alone, the clinical benefits of a combination of adapalene and doxycycline, the most frequently prescribed oral antibiotic for acne in the United States, have yet to be evaluated. OBJECTIVE AND METHODS: In a 12-week study, the efficacy and safety of the combination of adapalene gel 0.1% with doxycycline was compared with doxycycline alone for the treatment of severe acne. Subjects were randomized to receive doxycycline once daily in the morning and either adapalene or vehicle once daily in the evening. RESULTS: At Week 12, the combination adapalene-doxycycline was significantly superior to doxycycline alone for change from baseline in total (p<0.001), inflammatory (p=0.02), and noninflammatory (p<0.001) lesions. Significant differences in total lesions were observed as early as Week 4 (p=0.04). Both treatments were well tolerated, and no serious adverse events were reported. CONCLUSIONS: The study demonstrates that the combination of adapalene and an oral antibiotic provides a superior and faster benefit than antibiotic therapy alone and should be considered at the initiation of treatment.

Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis.

Owing to its anti-inflammatory, antipruritic, vasoconstrictive, and immune-modulating properties, clobetasol propionate is used to treat psoriasis. This study was conducted to evaluate the efficacy, safety, and cosmetic acceptability of clobetasol propionate lotion compared with its vehicle and with clobetasol propionate cream in the treatment of moderate to severe plaque-type psoriasis. A total of 222 patients were treated. After 4 weeks of treatment, clobetasol propionate lotion was more efficient than vehicle lotion and of equivalent efficacy as clobetasol propionate cream. Cosmetic acceptability was significantly better with clobetasol propionate lotion than with clobetasol propionate cream. Clobetasol propionate lotion was efficient, safe, and well tolerated and offers a significantly higher cosmetic advantage in the treatment of moderate to severe plaque-type psoriasis compared with clobetasol propionate cream.