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.
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.


OBJECTIVE
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.
Department of Dermatology and Venereology, Otto-von-Guericke University, Magdeburg, Germany.
A
A
Thielitz
A
A
Lux
A
A
Wiede
S
S
Kropf
E
E
Papakonstantinou
H
H
Gollnick
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003998:Dicarboxylic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005782:Gels; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods; D012720:Severity of Illness Index; D016037:Single-Blind Method; D055815:Young Adult
D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D005782:Gels; D000068816:Adapalene; C010038:azelaic acid