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Trial record 45 of 137 for:    acne AND peroxide

Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122457
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Anjali Shroff, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Official Title  ICMJE Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratosis
Intervention  ICMJE 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).
Study Arms  ICMJE 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
Intervention: Drug: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
40
Actual Study Completion Date  ICMJE July 19, 2018
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122457
Other Study ID Numbers  ICMJE GCO 15-1230
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anjali Shroff, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Bausch Health Americas, Inc.
Investigators  ICMJE
Principal Investigator: Anjali Shroff, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP