Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon)

Dermatology. 2001;203(1):38-44. doi: 10.1159/000051701.

Abstract

Background and 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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Acne Vulgaris / pathology
  • Adolescent
  • Adult
  • Alopecia / complications
  • Alopecia / pathology
  • Androgen Antagonists / adverse effects
  • Androgen Antagonists / therapeutic use*
  • Chlormadinone Acetate / adverse effects
  • Chlormadinone Acetate / therapeutic use*
  • Contraceptives, Oral, Synthetic / adverse effects
  • Contraceptives, Oral, Synthetic / therapeutic use*
  • Dermatitis, Seborrheic / complications
  • Dermatitis, Seborrheic / pathology
  • Ethinyl Estradiol / adverse effects
  • Ethinyl Estradiol / therapeutic use*
  • Ethinyl Estradiol-Norgestrel Combination / adverse effects
  • Ethinyl Estradiol-Norgestrel Combination / therapeutic use*
  • Female
  • Hirsutism / complications
  • Hirsutism / pathology
  • Humans
  • Single-Blind Method
  • Treatment Outcome

Substances

  • Androgen Antagonists
  • Belara
  • Contraceptives, Oral, Synthetic
  • Chlormadinone Acetate
  • Ethinyl Estradiol
  • Ethinyl Estradiol-Norgestrel Combination