Experience With Topical Acne Treatment

Wake Forest University (WFU)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Acne

Treatments: Drug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel; Drug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel; Drug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05582434

IRB00089304

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

One single fixed-combination product

Experimental group

Description:

Participants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily

Treatment:

Drug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel

Two products

Experimental group

Description:

Participants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily

Treatment:

Drug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel

Three products

Experimental group

Description:

Participants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily

Treatment:

Drug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel