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NCT03122457 · ClinicalTrials.gov registry record · Phase 2
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT03122457 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 22 participants.
The verdict
NCT03122457, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months.
Interventions
- DRUG lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03122457
The ClinicalTrials.gov registry entry for NCT03122457 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination is the first listed.
NCT03122457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03122457 about?
NCT03122457 is a clinical study titled "Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide". The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and ...
What is the current status of trial NCT03122457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2017-01-01. Estimated completion is 2018-07-19.
What interventions are being tested in trial NCT03122457?
The interventions under investigation include: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination (DRUG).
Who is sponsoring clinical trial NCT03122457?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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