Back to resultsPerimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Women 18 years or older
- Women who have had their first menses at least 12 months ago, and who currently have regular menses.
- Subjects must be able to read and understand English, and be able and willing to complete the survey.
- Subjects must have a self-reported complaint of peri-menstrual acne which has occurred monthly for the last 6 months.
- Subjects must be willing to forego any other therapy to the treatment area for the duration of the study.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
- Subjects must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
- Subjects must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
Exclusion Criteria:
- Male subjects.
- Post-menopausal women.
- Women who do not suffer from acne.
- Subjects who are allergic to clindamycin, benzoyl peroxide, lidocaine or any other ingredients listed in the study medication.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with ulcerative colitis or Crohn's disease.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of acne.
- Women who are pregnant, lactating, or planning to become pregnant during the study period.
- Subjects who have used any topical prescription medications on the study area within 30 days prior to Visit 2 / Baseline.
- Subjects on a stable dose of oral contraceptives for less than 6 months.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo
Arm Description
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Outcomes
Primary Outcome Measures
PGA Score
Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy
Secondary Outcome Measures
Adverse Event Severity
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.
Full Information
NCT ID
NCT03122457
First Posted
April 17, 2017
Last Updated
August 18, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03122457
Brief Title
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Official Title
Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bausch Health Americas, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Application of clindamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel to treat perimenstrual acne
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo
Arm Type
Experimental
Arm Description
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Intervention Type
Drug
Intervention Name(s)
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Intervention Description
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).
Primary Outcome Measure Information:
Title
PGA Score
Description
Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy
Time Frame
Day 99
Secondary Outcome Measure Information:
Title
Adverse Event Severity
Description
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.
Time Frame
Day 99
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18 years or older
Women who have had their first menses at least 12 months ago, and who currently have regular menses.
Subjects must be able to read and understand English, and be able and willing to complete the survey.
Subjects must have a self-reported complaint of peri-menstrual acne which has occurred monthly for the last 6 months.
Subjects must be willing to forego any other therapy to the treatment area for the duration of the study.
Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
Subjects must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
Subjects must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
Exclusion Criteria:
Male subjects.
Post-menopausal women.
Women who do not suffer from acne.
Subjects who are allergic to clindamycin, benzoyl peroxide, lidocaine or any other ingredients listed in the study medication.
Subjects with an unstable medical condition as deemed by the clinical investigator.
Subjects with ulcerative colitis or Crohn's disease.
Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of acne.
Women who are pregnant, lactating, or planning to become pregnant during the study period.
Subjects who have used any topical prescription medications on the study area within 30 days prior to Visit 2 / Baseline.
Subjects on a stable dose of oral contraceptives for less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Shroff, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
We'll reach out to this number within 24 hrs