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Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide

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ClinicalTrials.gov Identifier: NCT03122457
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Anjali Shroff, Icahn School of Medicine at Mount Sinai

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.

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)
Estimated Enrollment : 40 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)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Giselle Singer, BS 212-241-6033 giselle.singer@mssm.edu
Contact: Matthew Gagliotti 212-241-3288 matthew.gagliotti@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Giselle Singer, BS    212-241-3288    giselle.singer@mssm.edu   
Contact: Anjali Shroff, MD    212-241-3288    Anjali.Shroff@mssm.edu   
Principal Investigator: Anjali Shroff, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Anjali Shroff, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Anjali Shroff, Resident, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03122457     History of Changes
Other Study ID Numbers: GCO 15-1230
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anjali Shroff, Icahn School of Medicine at Mount Sinai:
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
C 1027
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents