Clinical trial NCT00656981: Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety & Efficacy of Oral Contraceptive Prep., Containing Drospirenone 3 mg/Ethinyl Estradiol 20 Mcg for 6 Treatment Cycles in Women With Moderate Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Moderate Acne Vulgaris
Acne
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 541
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
timeFrame: From baseline to Cycle 6.
Secondary outcomes:
measure: Change from baseline in count of papules
timeFrame: Visits 3-5
measure: Change from baseline in count of pustules
timeFrame: Visits 3-5
measure: Change from baseline in count of nodules
timeFrame: Visits 3-5
measure: Change from baseline in count of open comedones
timeFrame: Visits 3-5
measure: Change from baseline in count of closed comedones
timeFrame: Visits 3-5
measure: Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
timeFrame: Visits 3-5
measure: Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
timeFrame: Visits 3-5
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Kingman
country: United States
state: Arizona
city: Encino
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Castle Rock
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Palm Springs
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Shawnee
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Fridley
country: United States
state: Minnesota
city: East Steauket
country: United States
state: New York
city: New York
country: United States
state: New York
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Byran
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: