Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon).
OBJECTIVE
Acne in women can often be successfully treated by the intake of oral contraceptives containing gestagens with anti-androgenic properties. This study aimed to evaluate the efficacy of the monophasic oral contraceptive ethinylestradiol/chlormadinone acetate (EE/CMA; Belara for the treatment of mild to moderate papulopustular acne of the face and acne-related disorders in comparison to EE/levonorgestrel (LNG; Microgynon.


METHODS
199 female acne patients were enrolled in a single-blind, randomized, multicentre phase III study and divided into two groups who received either EE/CMA or EE/LNG. The primary end point was fulfilled if the number of papules/pustules per half of the face present on admission had decreased by at least 50% in the 12th medication cycle.


RESULTS
59.4% of the women under EE/CMA and 45.9% under EE/LNG were responders. The relative frequency of women with complete resolution was 16.5% under EE/CMA and 4.3% under EE/LNG at cycle 12.


CONCLUSIONS
EE/CMA is an efficient treatment for women with mild and moderate papulopustular acne of the face and related disorders, reflecting the well-known anti-androgenic properties of the progestogen CMA.
Worret
I
I
Department of Dermatology, University Hospital Munich, Germany. Wolf-Ingo.Worret@lrz.tu-muenchen.de
Arp
W
W
Zahradnik
H P
HP
Andreas
J O
JO
Binder
N
N
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000505:Alopecia / Q000150:complications / Q000473:pathology; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D002715:Chlormadinone Acetate / Q000009:adverse effects / Q000627:therapeutic use*; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D012628:Dermatitis, Seborrheic / Q000150:complications / Q000473:pathology; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006628:Hirsutism / Q000150:complications / Q000473:pathology; D006801:Humans; D016037:Single-Blind Method; D016896:Treatment Outcome
D000726:Androgen Antagonists; C112985:Belara; D003280:Contraceptives, Oral, Synthetic; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination