Experience With Topical Acne Treatment

Acne Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582434
• Other study ID #: IRB00089304
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Irma M Richardson, MHA
• Phone: 336-716-2903
• Email: irichard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Adapalene Gel
Single topical treatment arm topical to be applied daily to area affected
• Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
Two topical treatments will be dispensed and instructions to apply daily to affected area
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lott R, Taylor SL, O'Neill JL, Krowchuk DP, Feldman SR. Medication adherence among acne patients: a review. J Cosmet Dermatol. 2010 Jun;9(2):160-6. doi: 10.1111/j.1473-2165.2010.00490.x. — View Citation

Moradi Tuchayi S, Alexander TM, Nadkarni A, Feldman SR. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016 Oct 11;10:2091-2096. doi: 10.2147/PPA.S117437. eCollection 2016. — View Citation

Tan X, Al-Dabagh A, Davis SA, Lin HC, Balkrishnan R, Chang J, Feldman SR. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris. Am J Clin Dermatol. 2013 Jun;14(3):243-51. doi: 10.1007/s40257-013-0016-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached	End of study visit - day 56
Primary	Medication Adherence	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	Gender specific adherence (female subjects)	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
Secondary	Gender specific adherence (male subjects)	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