Clincosm LogoSign in Get a demo

Experience With Topical Acne Treatment

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05582434
Collaborator
Bausch Health Americas, Inc. (Industry)
72
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

Condition or Disease Intervention/Treatment Phase
  • Drug: Adapalene Gel
  • Drug: Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
  • Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: One gel treatment

Every participant will be instructed to apply a topical retinoid every day.

Drug: Adapalene Gel
Single topical treatment arm topical to be applied daily to area affected
Other Names:
  • Differin

    		•
    Experimental: Two gel treatment

    One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day.

    Drug: Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
    Two topical treatments will be dispensed and instructions to apply daily to affected area
    Other Names:
  • Differin and ONEXTON

    		•
    Experimental: Three gel treatment

    One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.

    Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
    Three topical treatments will be dispensed and instructions to apply daily to affected area arm.
    Other Names:
  • Differin, Epsolay, Clindamycin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Medication Adherence [End of study visit - day 56]

      Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached

    2. Medication Adherence [End of study visit - day 56]

      Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened

    Secondary Outcome Measures

    1. Gender specific adherence (female subjects) [End of study visit - day 56]

      Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome

    2. Gender specific adherence (male subjects) [End of study visit - day 56]

      Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adult patients ≥18 years of age

    2. Patients with a current diagnosis of acne

    3. Patients who live in the US,

    4. Patients have sufficient command of the English language

    Exclusion Criteria:

    1. Patients less than the age of 18

    2. Patients without a current diagnosis of acne

    3. Patients who do not live in the US

    4. Patients without a sufficient command of the English language

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • Bausch Health Americas, Inc.

    Investigators

    • Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05582434
    Other Study ID Numbers:
    • IRB00089304
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Clindamycin
    Clindamycin palmitate
    Clindamycin phosphate
    Adapalene
    Benzoyl Peroxide

    Study Results

    No Results Posted as of Feb 2, 2023