Experience With Topical Acne Treatment

Early Phase 1

Recruiting

• Conditions: Acne
• Interventions: Drug: Adapalene Gel; Drug: Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel; Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.

• Registration Number: NCT05582434
• Lead Sponsor: Wake Forest University Health Sciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Study Start: 2024-02-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One gel treatment	Adapalene Gel	Every participant will be instructed to apply a topical retinoid every day.
Two gel treatment	Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel	One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day.
Three gel treatment	adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.	One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States