A randomized investigator‐blind parallel‐group study to assess efficacy and safety of azelaic acid 15% gel vs. adapalene 0.1% gel in the treatment and maintenance treatment of female adult acne. (14th November 2014)

• Record Type: Journal Article
• Authors: Thielitz, A.; Lux, A.; Wiede, A.; Kropf, S.; Papakonstantinou, E.; Gollnick, H.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 29:Number 4(2015:Apr.)
• Page Start: 789
• Page End: 796
• Publication Date: 2014-11-14
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.12823
• Languages: English
• ISSNs: 0926-9959

Abstract

Abstract: Background: Growing numbers of post‐adolescent females are suffering from treatment‐resistant or relapsing adult acne forms, therefore requiring the definition of safe and effective treatment options for this burdening disease. Objectives: To assess the efficacy of azelaic acid 15% gel (AzA) vs. no treatment during maintenance therapy of female adult acne and to compare its efficacy and safety vs. adapalene 0.1% gel (AD) during a 9‐month period (3‐month treatment and 6‐month maintenance treatment). Methods: A total of 55 women between 18 and 45 years with adult acne were included in this investigator‐blind trial and randomized into three groups receiving AzA gel b.i.d. for 9 months (AzA9M, n = 17) or AzA gel b.i.d. for 3 months followed by a 6‐month observational phase (AzA3M, n = 19) or AD gel once daily for 9 months (AD9M, n = 19). Parameters of efficacy, safety and patient‐related factors were analysed. Results: The reduction in lesion counts, severity and Dermatology Life Quality Index score was significant ( P < 0.05) and comparable between groups during the treatment phase, while dryness and scaling were significantly lower ( P < 0.05) in group AzA9M vs. AD9M. During maintenance, AzA9M was superior to AzA3M in the control of inflammatory lesions ( P = 0.008) and total lesions ( P = 0.014) at week 24. From week 12 to week 36, a mild relative increase in inflammatory lesions could be observed in all groups. In AzA3M, this increase exceeded that of AzA9M by 23.1% ( P = 0.109), while the difference of total lesions diverged to 30.8% ( P = 0.038). No significant differences could be detected between AzA9M and AD9M. Group AzA9M was non‐inferior to AD9M (non‐inferiority margin of 50% for the confidence limit for the relative effect) in the control of inflammatory acne lesions. Conclusions: AzA15% gel is a safe and effective treatment and maintenance treatment of female adult acne with non‐inferior efficacy to AD 0.1% gel in the control of inflammatory acne.