Evaluate Safety & Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00651469

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: YAZ (DRSP 3 mg/EE 0.02 mg (as Beta-Cyclodextrin Clathrate)) Drug: Placebo	Phase III

MedlinePlus related topics: Acne

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol 1,2-Dihydrospirorenone Betadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Bayer:

Primary Outcome Measures:

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. [ Time Frame: From baseline to Cycle 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in count of papules [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Change from baseline in count of pustules [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Change from baseline in count of nodules [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Change from baseline in count of open comedones [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Change from baseline in count of closed comedones [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating [ Time Frame: Visits 3-5 ] [ Designated as safety issue: No ]

Enrollment:	500
Study Start Date:	January 2003
Study Completion Date:	July 2004

Arms	Assigned Interventions
Arm 1: Experimental n/a	Drug: YAZ (DRSP 3 mg/EE 0.02 mg (as Beta-Cyclodextrin Clathrate)) The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack. Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
Arm 2: Placebo Comparator n/a	Drug: Placebo The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)

Arms

Assigned Interventions

Arm 1: Experimental

n/a

Drug: YAZ (DRSP 3 mg/EE 0.02 mg (as Beta-Cyclodextrin Clathrate))

The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.

Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).

Arm 2: Placebo Comparator

n/a

Drug: Placebo

The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)

Eligibility

Ages Eligible for Study:	14 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651469

Show 25 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Publications indexed to this study:

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.

Responsible Party:	( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers:	91209, 306820
Study First Received:	March 31, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00651469
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Moderate Acne Vulgaris
Acne

Study placed in the following topic categories:

Facial Dermatoses
Skin Diseases
Facies
Estradiol valerate
Ethinyl Estradiol
Sebaceous Gland Diseases
Estradiol 17 beta-cypionate

Acne Vulgaris
Estradiol
Exanthema
Estradiol 3-benzoate
Drospirenone
Polyestradiol phosphate

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 16, 2009