BACKGROUND AND OBJECTIVE: Acne-prone skin, a common skin condition not only in adolescents but also in adults, can significantly influence the affected individual's quality of life. The aim of this open-label, prospective, single-centre, phase IV study was to investigate the effects of an oral contraceptive containing chlormadinone 2 mg and ethinylestradiol 0.03 mg (Belara) on the physiology of acne-prone facial skin in healthy women aged 18-37 years. METHODS: Forty-four Caucasian women requesting hormonal contraception divided into two age groups (group A: 18-27 years; group B: 28-37 years) were treated with chlormadinone/ethinylestradiol for six menstrual cycles. During each treatment phase, each subject took one tablet per day for 21 consecutive days, followed by a 7-day pill-free interval. Medication was commenced on the first day of menses. Changes in skin parameters were evaluated in terms of the clinical sum score (the primary outcome variable, calculated from the number of comedones, the number of papules/papulopustules, and the sebum secretion state), the evaluation of the pore size using standardized photography, and a range of biophysical in vivo measurements, assessed at baseline, after 12 weeks and after 24 weeks. RESULTS: In both age groups, facial skin condition as quantified by the clinical sum score improved significantly after three and six treatment cycles, with reduced numbers of acne lesions (comedones and papules/papulopustules) and a reduction in seborrhoea. Moreover, there was a statistically significant decrease in pore size. Biophysical evaluations confirmed favourable effects of the medication on diverse skin parameters. Skin surface pH remained within the normal physiological range and there was an improvement in epidermal barrier function (as manifested by decreased transepidermal water loss from the skin of the forehead). Stratum corneum hydration increased in both age groups and the lipid content of the skin surface on the forehead decreased significantly after three treatment cycles in subjects aged 28-37 years. Ultrasound measurements verified that there was no retention of water within the dermis. There was no difference between the two age groups. CONCLUSION: For the first time, improvements in several facial skin parameters during treatment with a combined oral contraceptive (chlormadinone/ethinyl-estradiol) were quantified by biophysical methods and a clinical sum score. The highly statistically significant improvements in clinical findings and various biophysical skin parameters observed in this study suggest that the antiandrogenic oral contraceptive chlormadinone/ethinylestradiol may be a major therapy option in women with acne-prone skin who request hormonal contraception.
BACKGROUND AND OBJECTIVE: Acne-prone skin, a common skin condition not only in adolescents but also in adults, can significantly influence the affected individual's quality of life. The aim of this open-label, prospective, single-centre, phase IV study was to investigate the effects of an oral contraceptive containing chlormadinone 2 mg and ethinylestradiol 0.03 mg (Belara) on the physiology of acne-prone facial skin in healthy women aged 18-37 years. METHODS: Forty-four Caucasian women requesting hormonal contraception divided into two age groups (group A: 18-27 years; group B: 28-37 years) were treated with chlormadinone/ethinylestradiol for six menstrual cycles. During each treatment phase, each subject took one tablet per day for 21 consecutive days, followed by a 7-day pill-free interval. Medication was commenced on the first day of menses. Changes in skin parameters were evaluated in terms of the clinical sum score (the primary outcome variable, calculated from the number of comedones, the number of papules/papulopustules, and the sebum secretion state), the evaluation of the pore size using standardized photography, and a range of biophysical in vivo measurements, assessed at baseline, after 12 weeks and after 24 weeks. RESULTS: In both age groups, facial skin condition as quantified by the clinical sum score improved significantly after three and six treatment cycles, with reduced numbers of acne lesions (comedones and papules/papulopustules) and a reduction in seborrhoea. Moreover, there was a statistically significant decrease in pore size. Biophysical evaluations confirmed favourable effects of the medication on diverse skin parameters. Skin surface pH remained within the normal physiological range and there was an improvement in epidermal barrier function (as manifested by decreased transepidermal water loss from the skin of the forehead). Stratum corneum hydration increased in both age groups and the lipid content of the skin surface on the forehead decreased significantly after three treatment cycles in subjects aged 28-37 years. Ultrasound measurements verified that there was no retention of water within the dermis. There was no difference between the two age groups. CONCLUSION: For the first time, improvements in several facial skin parameters during treatment with a combined oral contraceptive (chlormadinone/ethinyl-estradiol) were quantified by biophysical methods and a clinical sum score. The highly statistically significant improvements in clinical findings and various biophysical skin parameters observed in this study suggest that the antiandrogenic oral contraceptive chlormadinone/ethinylestradiol may be a major therapy option in women with acne-prone skin who request hormonal contraception.