Experience With Topical Acne Treatment

March 27, 2024 updated by: Wake Forest University Health Sciences

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: End of study visit - day 56
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
End of study visit - day 56
Medication Adherence
Time Frame: 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
End of study visit - day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender specific adherence (female subjects)
Time Frame: 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
End of study visit - day 56
Gender specific adherence (male subjects)
Time Frame: 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
End of study visit - day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Bausch Health Americas, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00089304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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