Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
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| ClinicalTrials.gov Identifier: NCT00651469 |
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Recruitment Status :
Completed
First Posted : April 2, 2008
Last Update Posted : December 30, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acne Vulgaris | Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) Drug: Placebo | Phase 3 |
Expanded Access : Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 534 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2003 |
| Actual Study Completion Date : | July 2004 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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). |
| Placebo Comparator: Arm 2 |
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) |
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 ]
Secondary Outcome Measures :
- Change from baseline in count of papules [ Time Frame: Visits 3-5 ]
- Change from baseline in count of pustules [ Time Frame: Visits 3-5 ]
- Change from baseline in count of nodules [ Time Frame: Visits 3-5 ]
- Change from baseline in count of open comedones [ Time Frame: Visits 3-5 ]
- Change from baseline in count of closed comedones [ Time Frame: Visits 3-5 ]
- Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating [ Time Frame: Visits 3-5 ]
- Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating [ Time Frame: Visits 3-5 ]
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| Ages Eligible for Study: | 14 Years to 45 Years (Child, Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651469
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35209 | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Mesa, Arizona, United States, 85201 | |
| United States, California | |
| Los Angeles, California, United States, 90010 | |
| San Diego, California, United States, 92108 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010-2975 | |
| United States, Florida | |
| Miami, Florida, United States, 33175 | |
| St. Petersburg, Florida, United States, 33702 | |
| Tampa, Florida, United States, 33607 | |
| United States, Idaho | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60631 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Massachusetts | |
| Wellesley, Massachusetts, United States, 02481 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64114 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45230 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| United States, Rhode Island | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| Austin, Texas, United States, 78759 | |
| Dallas, Texas, United States, 75230 | |
| Houston, Texas, United States, 77024 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00651469 |
| Other Study ID Numbers: |
91209 306820 ( Other Identifier: Company Internal ) |
| First Posted: | April 2, 2008 Key Record Dates |
| Last Update Posted: | December 30, 2014 |
| Last Verified: | December 2014 |
Keywords provided by Bayer:
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Moderate Acne Vulgaris Acne |
Additional relevant MeSH terms:
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Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |