Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

Bayer

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Diane; Drug: Placebo; Drug: Valette

Study type: Interventional

Funder types: Industry

Identifiers

NCT00280657

307760

91299

Details and patient eligibility

About

The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Full 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.

Enrollment: 1,326 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mild to moderate facial papulopustular acne

Exclusion criteria

• Contraindication against use of hormonal contraceptives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,326 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Valette

Arm 2

Active Comparator group

Treatment:

Drug: Diane

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo