Clinical trial NCT00651469: Evaluate Safety and Efficacy of an OC Preparation vs 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: 2008-04-02
Enrollment: 534
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 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

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: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Wellesley
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Winston-Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Koltun W, Maloney JM, Marr J, Kunz M. Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 mug plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.
citation: Maloney JM, Dietze P Jr, Watson D, Niknian M, Lee-Rugh S, Sampson-Landers C, Korner P. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):773-81. doi: 10.1097/AOG.0b013e318187e1c5.