Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin (SKADI)
The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy on the maintenance of clinical therapy success in subjects with mild to moderate acne vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and safety during a 9-month long-term treatment period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Phase IV An Evaluator-Blind Controlled Parallel-Group Study To Assess Efficacy And Safety Of Skinoren® 15% Gel And Differin® 0,1% Gel For The Treatment And Maintenance Treatment Of Facial Acne Vulgaris And Late-Type Acne In Females|
- Superiority of Skinoren 15% Gel [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Superiority of Skinoren 15% Gel-group over the observational group in the maintanance phase. Change of Global Severity Grades (ISGA and Leeds)
- Non-inferiority of Skinoren 15 % gel over the Differin 0.1% gel [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Non-inferiority of Skinoren 15% Gel over the current "gold standard" Differin 0.1% gel in the long-term-treatment period: Change of Global severity grades
- - Change of non-inflammatory, inflammatory and total lesions at all visits. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- Secondary Endpoints:
Microcomedone count changes from week 12-36
- Change of non-inflammatory, inflammatory and total lesions at all visits [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Subjects efficacy assessment
- change of non-inflammatory, inflammatory and total lesions at all visits [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]subjects tolerability assessment
- Change of non-inflammatory, inflammatory and total lesions at all visits [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Subjects DLQI assessment
- change of non-inflammatory, inflammatory and total lesions at all visits [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Investigators tolerability assessment
- change of non-inflammatory, inflammatory and total lesions at all visits [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Relapse rate: Number of subjects which lose more than 50% of their initial improvement achieved at maintanance phase
|Study Start Date:||August 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Skinoren gel 15 %, topical
primary treatment 12 weeks with Skinoren gel®, followed by maintenance therapy with Skinoren gel® for another 24 weeks,
gel 15%, twice daily, 36 weeks
Other Name: Generikum
Active Comparator: Differin Gel 0.1%
primary 12 weeks therapy with Differin gel®, followed by maintenance therapy with Differin gel® for another 24 weeks.
0.1% gel, once daily in the evening
Other Name: Epiduo
primary 12 weeks therapy with Skinoren gel®, followed by observation only for another 24 weeks,
12 weeks treatment, the following 24 months only observation
Other Name: Generikum
Differin gel, containing adapalene 0.1%, has been used now for several years in the topical treatment of mild to moderate acne. It has comedolytic and anti-inflammatory activities,and is equally effective and less irritant than other topical retinoids. Adapalene has been shown to maintain therapeutic effect achieved after three months of monotherapy for further three months. Furthermore, its effect in maintenance therapy has been shown in several studies after initial combination with topical or systemic antimicrobials. Skinoren 15% gel (azelaic acid) is an alternative treatment affecting several pathogenetic factors of acne, which has potential in maintenance therapy due to its good tolerability and safety and missing contraindications concerning long-term treatment, which allow even use in pregnancy.
Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes. The 15 % azelaic acid gel has recently proven efficacy in a maintenance treatment of papulopustular rosacea after a combination treatment with oral doxycycline.
Mild to moderate acne vulgaris is defined as global severity of 2 through 4, according to the Investigator´s Static Global Assessment (ISGA) and Leeds Revised Acne Grading Scale from 2 trough 7.This inclusion criterion corresponds to the clinical grades usually treated with topical anti-acne therapies.
The non-treatment group during the maintenance phase helps to demonstrate the efficacy of Skinoren 15% gel in a maintenance treatment, thereby corroborating the necessity for maintenance therapy reflecting acne as a chronic disease.
Acne lesion counting has been used widely in the evaluation of new acne treatments as a change in facial acne lesions counts over time in an individual patient could reflect a true change. However, lesion counts are more valid in greater patient populations as planned in this study. Therefore, the lesion counts are defined as secondary efficacy criteria except during the maintenance phase for the population treated with azelaic acid. As described before, microcomedones are considered as precursor lesion. Moreover, their counts are constantly reduced during acne treatment and precede the clinical relapse. Therefore, microcomedones counts will be used in this trial as a marker of maintenance of therapeutic effect achieved during initial treatment phase.
|Clinic for Dermatology and Vereology, Central Hospital Magdeburg|
|Magdeburg, Saxony-Anhalt, Germany, 39120|
|Principal Investigator:||Anja Thielitz, Dr. med.||unfillated|