Are oral contraceptives (OCPs) with anti-androgenic progestins preferred over other OCPs in patients with acne?

ABSTRACT

BACKGROUND: Some women with acne may suffer from a hypersensitivity of the sebaceous glands to androgens. The use of OCPs with anti-androgenic properties may therefore be a useful approach to treating these patients.

POPULATION STUDIED: The population studied included 199 women 18 to 40 years of age (smokers up to age 30 years), with mild to moderate papulo pustular acne of the face and acne-related disorders. Patients were recruited from 32 office-based gynecology centers in Germany.

STUDY DESIGN AND VALIDITY: Patients were randomized in an investigator blinded-only fashion (nonconcealed allocation assignment) to 12 treatment cycles with one of 2 OCPs—either Belara, a monophasic OCP containing 0.3 mg of ethinylestradiol and 2 mg of chlormadinone acetate (EE/CMA), a progestogen derivative with anti-androgenic properties or Microgynon, an OCP containing an equal dose of estrogen and a more commonly used progestin, levonorgestrel (EE/LNG). Blinded observers performed regular skin exams after cycles 4, 7, 10 and 12. Women were not allowed to use any other treatments for acne.

OUTCOMES MEASURED: The primary endpoint was the number of papules/pustules per half of the face decreasing by 50% in the 12th medication cycle. Secondary endpoints were the assessment of comedomal acne of the face, acne of the décolleté and back, further signs of adrogenization, such as seborrhea, alopecia, and hirsuitism. Blood levels of androgens, SHBG, cycle stability and incidence of adverse events were also examined.

RESULTS: A total of 59% of patients on EE/CMA compared with 46% on EE/LNG showed a 50% reduction in the number of papules/pustules after 12 treatment cycles (P=.02; number needed to treat=8). The number of women with complete resolution reached 16.5% by cycle 12 in those taking EE/CMA compared with 4.3% by cycle 12 in the EE/LNG group (difference nonsignificant). Similar nonsignificant trends were seen for a reduction in comedonal acne favoring the EE/CMA group. Equal improvements were seen in each group for seborrhea, alopecia, and hirsuitism. There was no difference in the incidence and intensity of break-through bleeding or amenorrhea between the 2 groups. Adverse events were similar between the 2 groups.

ABSTRACT

BACKGROUND: Some women with acne may suffer from a hypersensitivity of the sebaceous glands to androgens. The use of OCPs with anti-androgenic properties may therefore be a useful approach to treating these patients.

POPULATION STUDIED: The population studied included 199 women 18 to 40 years of age (smokers up to age 30 years), with mild to moderate papulo pustular acne of the face and acne-related disorders. Patients were recruited from 32 office-based gynecology centers in Germany.

STUDY DESIGN AND VALIDITY: Patients were randomized in an investigator blinded-only fashion (nonconcealed allocation assignment) to 12 treatment cycles with one of 2 OCPs—either Belara, a monophasic OCP containing 0.3 mg of ethinylestradiol and 2 mg of chlormadinone acetate (EE/CMA), a progestogen derivative with anti-androgenic properties or Microgynon, an OCP containing an equal dose of estrogen and a more commonly used progestin, levonorgestrel (EE/LNG). Blinded observers performed regular skin exams after cycles 4, 7, 10 and 12. Women were not allowed to use any other treatments for acne.

OUTCOMES MEASURED: The primary endpoint was the number of papules/pustules per half of the face decreasing by 50% in the 12th medication cycle. Secondary endpoints were the assessment of comedomal acne of the face, acne of the décolleté and back, further signs of adrogenization, such as seborrhea, alopecia, and hirsuitism. Blood levels of androgens, SHBG, cycle stability and incidence of adverse events were also examined.

RESULTS: A total of 59% of patients on EE/CMA compared with 46% on EE/LNG showed a 50% reduction in the number of papules/pustules after 12 treatment cycles (P=.02; number needed to treat=8). The number of women with complete resolution reached 16.5% by cycle 12 in those taking EE/CMA compared with 4.3% by cycle 12 in the EE/LNG group (difference nonsignificant). Similar nonsignificant trends were seen for a reduction in comedonal acne favoring the EE/CMA group. Equal improvements were seen in each group for seborrhea, alopecia, and hirsuitism. There was no difference in the incidence and intensity of break-through bleeding or amenorrhea between the 2 groups. Adverse events were similar between the 2 groups.

ABSTRACT

BACKGROUND: Some women with acne may suffer from a hypersensitivity of the sebaceous glands to androgens. The use of OCPs with anti-androgenic properties may therefore be a useful approach to treating these patients.

POPULATION STUDIED: The population studied included 199 women 18 to 40 years of age (smokers up to age 30 years), with mild to moderate papulo pustular acne of the face and acne-related disorders. Patients were recruited from 32 office-based gynecology centers in Germany.

STUDY DESIGN AND VALIDITY: Patients were randomized in an investigator blinded-only fashion (nonconcealed allocation assignment) to 12 treatment cycles with one of 2 OCPs—either Belara, a monophasic OCP containing 0.3 mg of ethinylestradiol and 2 mg of chlormadinone acetate (EE/CMA), a progestogen derivative with anti-androgenic properties or Microgynon, an OCP containing an equal dose of estrogen and a more commonly used progestin, levonorgestrel (EE/LNG). Blinded observers performed regular skin exams after cycles 4, 7, 10 and 12. Women were not allowed to use any other treatments for acne.

OUTCOMES MEASURED: The primary endpoint was the number of papules/pustules per half of the face decreasing by 50% in the 12th medication cycle. Secondary endpoints were the assessment of comedomal acne of the face, acne of the décolleté and back, further signs of adrogenization, such as seborrhea, alopecia, and hirsuitism. Blood levels of androgens, SHBG, cycle stability and incidence of adverse events were also examined.

RESULTS: A total of 59% of patients on EE/CMA compared with 46% on EE/LNG showed a 50% reduction in the number of papules/pustules after 12 treatment cycles (P=.02; number needed to treat=8). The number of women with complete resolution reached 16.5% by cycle 12 in those taking EE/CMA compared with 4.3% by cycle 12 in the EE/LNG group (difference nonsignificant). Similar nonsignificant trends were seen for a reduction in comedonal acne favoring the EE/CMA group. Equal improvements were seen in each group for seborrhea, alopecia, and hirsuitism. There was no difference in the incidence and intensity of break-through bleeding or amenorrhea between the 2 groups. Adverse events were similar between the 2 groups.