Acne Vulgaris
Conditions
Keywords
Acne papulopustulosa
Brief summary
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Interventions
DRUGValette
1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
DRUGDiane
1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
DRUGPlacebo
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with mild to moderate facial papulopustular acne
Exclusion criteria
* Contraindication against use of hormonal contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lesions | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| ISGA | 6 months |
| Parameters of safety and tolerability | 6 months |
Countries
Czechia, Poland, Russia, Slovakia, Ukraine
Outcome results
None listed