Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
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|ClinicalTrials.gov Identifier: NCT03122457|
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Application of clindamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel to treat perimenstrual acne|
|Masking:||None (Open Label)|
|Official Title:||Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||July 19, 2018|
|Actual Study Completion Date :||July 19, 2018|
Experimental: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Drug: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
At Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. 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).
- PGA Score [ Time Frame: Day 99 ]Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system.
- Adverse Event Severity [ Time Frame: Day 99 ]Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122457
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Anjali Shroff, MD||Icahn School of Medicine at Mount Sinai|