Evaluate Safety &Amp; Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00651469
First received: March 31, 2008
Last updated: October 10, 2013
Last verified: October 2013

March 31, 2008
October 10, 2013
January 2003
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00651469 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluate Safety &Amp; Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • 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).
  • 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)
  • Experimental: Arm 1
    Intervention: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
July 2004
Not Provided

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
Female
14 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00651469
91209, 306820
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP