Overview

Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
Female
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
Treatments:
Contraceptive Agents
Contraceptives, Oral
Criteria
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
peelings, 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