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Completed

NCT Number: NCT00280657

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chomutov, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mild to moderate facial papulopustular acne

Exclusion criteria

  • Contraindication against use of hormonal contraceptives

Treatment and study plan

Valette

Drug

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

Diane

Drug

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

Placebo

Drug

2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

Primary outcomes

  1. Change in lesions

    Time frame: 6 months

Secondary outcomes

  1. ISGA

    Time frame: 6 months

  2. Parameters of safety and tolerability

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 23, 2006
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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