Efficacy of the oral contraceptive Belara® in acne resolution
rates: a randomised, double-blind, placebo-controlled phase III-trial
A
Mendelin
Grünenthal GmbH, Aachen, Germany
This study assessed the effects of
the monophasic combined oral contraceptive (COC) Belara® (0.03 mg
ethinylestradiol and 2 mg chlormadinone acetate, EE/CMA) on papulopustular and
comedonal acne of the face, the décolleté and back, on seborrhea, alopecia and
hirsutism. A total of 377 women were randomised (2:1) to receive either EE/CMA
(n=251) or placebo (n=126) for 6 medication cycles. Due to the placebo control
and the double-blind design of the study condoms were supplied for contraception.
The primary efficacy endpoint was defined as a reduction of at least 50% in the
number of papules/pustules of the face from admission to medication cycle 6.
This reduction was seen in 64.1% of subjects (161/251) treated with EE/CMA in
contrast to 43.7% of subjects (55/126) on placebo (p=0.0001). The median
reduction of papules/pustules on the face compared to admission was 63.6% in the
COC group compared to 45.3% in the placebo group. EE/CMA was also superior to
placebo with regard to secondary efficacy parameters. For comedonal acne of the
face the reduction of lesions was 54.7% (EE/CMA) compared to 32.4 % on placebo.
Papulopustular acne of the décolleté decreased by 92.9% (EE/CMA) compared to
50% with placebo. Papulopustular acne of the back decreased by 86.0% in subjects
on EE/CMA and 58.3% on placebo. Reflecting these results, 39.9% of subjects on
EE/CMA reported an excellent improvement or complete resolution of acne compared
to 12.7% on placebo. These clinical findings were associated with reduced free
testosterone and other androgen levels in the EE/CMA, but not in the placebo
group. Furthermore, a marked increase of sex hormone-binding globulin was
measured in the EE/CMA but not in the placebo group. In addition to its
contraceptive efficacy described elsewhere, EE/CMA is an effective treatment for
moderate papulopustular acne and other androgen-related disorders.