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Completed Phase 2 Interventional Results available

Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide

ClinicalTrials.gov ID: NCT03122457

Public ClinicalTrials.gov record NCT03122457. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03122457
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
22 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2016
Primary completion
Jul 18, 2018
Completion
Jul 18, 2018
Last update posted
Sep 3, 2020

2017 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Icahn School of Medicine at Mount Sinai New York New York 10029

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03122457, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03122457 live on ClinicalTrials.gov.

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