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NCT01015638 · ClinicalTrials.gov registry record · Phase 4
Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
A Phase 4 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01015638: Completed Phase 4 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
NCT01015638 is a Phase 4 study of Acne Vulgaris that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 36 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015638, a Phase 4 study of Acne Vulgaris, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
Primary Outcome
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion
Conditions Studied
Interventions
- DRUG Clindamycin and BPO 5% gel
- DRUG Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Study Locations (1)
Pennsylvania
- cyberDERM - Broomall
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-08 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT01015638 record still lists
NCT01015638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Clindamycin and BPO 5% gel is the first listed.
NCT01015638 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01015638 about?
NCT01015638 is a clinical study titled "Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications". This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the...
What is the current status of trial NCT01015638?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2009-08. Estimated completion is 2009-09.
What conditions does trial NCT01015638 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT01015638?
The interventions under investigation include: Clindamycin and BPO 5% gel (DRUG), Clindamycin phosphate and benzoyl peroxide 2.5% gel. (DRUG).
Who is sponsoring clinical trial NCT01015638?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01015638 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01015638's enrollment target sits among peer trials
36 51st of 67 higher than 17 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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