Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.

Bayer

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651469

91209

306820 (Other Identifier)

Details and patient eligibility

About

The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.

Enrollment

534 patients

Sex

Female

Ages

14 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (<5mm) on the face).

Exclusion criteria

Standard contraindications for use of combined oral contraceptives (class label) plus
Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical pellings, mechanical extraction of comedones)
Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics