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NCT00722761 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
A Phase 3 study of Acne Vulgaris, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00722761: Completed Phase 3 study of Acne Vulgaris, sponsored by Massachusetts General Hospital.
NCT00722761 is a Phase 3 study of Acne Vulgaris that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00722761, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo tablet
- DRUG drospirenone and ethinyl estradiol
Study Locations (1)
Massachusetts
- Clinical Unit for Research Trials in Skin - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT00722761 record still lists
NCT00722761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Placebo tablet is the first listed.
NCT00722761 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00722761 about?
NCT00722761 is a clinical study titled "Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne". 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 (s...
What is the current status of trial NCT00722761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2009-04. Estimated completion is 2012-04.
What conditions does trial NCT00722761 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT00722761?
The interventions under investigation include: Placebo tablet (DRUG), drospirenone and ethinyl estradiol (DRUG).
Who is sponsoring clinical trial NCT00722761?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00722761 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00722761's enrollment target sits among peer trials
30 52nd of 67 higher than 13 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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