Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne

NCT00722761 | Completed Phase 3 Results

• 1 other identifier: 2008-P-000754
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating acne on the trunk (the main part of the body that does not include the arms, legs, and head). Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and cysts on the face, neck, upper chest, and upper back. YAZ is a combination birth control pill. A "combination" pill means that it is made up of more than one major ingredient. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries responsible for the typical female features. Progestins are steroid hormones produced by the ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male sex hormones (androgens) that cause acne. The study drug being used in this study is called YAZ. It has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive for birth control. In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo looks like the study drug but contains no active drug (like a sugar pill). We use placebos in research studies to learn if the effects seen in research subjects are truly from the study drug or from other reasons.

Conditions

Acne Vulgaris

Keywords

YAZ; oral contraceptive; Acne vulgaris

Outcome Measures

Primary Outcomes (1)

• Percent Change in Truncal Lesion Counts

  Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.

  0-24 weeks

Secondary Outcomes (1)

• Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination

  24 weeks

Study Arms (2)

Drosperinone and Ethinyl estradiol

ACTIVE COMPARATOR

Drospirenone and Ethinyl estradiol (3mg/0.02mg)(YAZ)tablet once a day

Drug: drospirenone and ethinyl estradiol

Placebo tablet

PLACEBO COMPARATOR

Placebo tablet once a day

Drug: Placebo tablet

Interventions

drospirenone and ethinyl estradiol DRUG

Drosperinone (3mg) and ethinyl estradiol (0.02mg) tablet given once daily for 24 weeks

Also known as: YAZ

Drosperinone and Ethinyl estradiol

Placebo tablet DRUG

Placebo tablet (no active drug) given once daily for 24 weeks

Also known as: Placebo

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female Subjects 18-45 years of age who have achieved spontaneous menarche.
• A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control.
• A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined.
• Maximum of 5 nodules.
• Willing and able to understand and sign informed consent.
• Able to complete study and comply with study procedures.

You may not qualify if:

• Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
• Use of oral antibiotics within 30 days.
• Use of systemic corticosteroids within 4 weeks.
• Use of oral contraceptives within 12 weeks.
• Use of isotretinoin in past six months.
• Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week.
• Use of tanning booths or lamps within 1 week prior to baseline.
• BMI \>30
• History of renal insufficiency
• History of hepatic dysfunction
• History of adrenal Insufficiency
• History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
• History of hypertension
• Diabetes mellitus with vascular involvement
• Migraine headaches with focal neurological symptoms

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bayer: collaborator

Study Sites (1)

Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

drospirenone; Ethinyl Estradiol; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Early termination leading to small number of subjects analyzed

Results Point of Contact

• Title: Alexa B. Kimball
• Organization: MGH Curtis

harvardskinstudies@partners.org

617-726-5066

Study Officials

• Alexandra B. Kimball, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Unit for Research Trials in Skin

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 5, 2013
• Results First Posted: March 5, 2013

Record last verified: 2013-01

Locations

US (1)