Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): skinoren; differin; skinoren
Intervention type(s): Drug; Drug; Drug
Intervention description(s): gel 15%, twice daily, 36 weeks; 0.1% gel, once daily in the evening; 12 weeks treatment, the following 24 months only observation
Other intervention name(s): Generikum; Epiduo; Generikum
Intervention MeSH terms: Adapalene; Azelaic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: acne vulgaris; late-type acne; Skinoren; maintenance