Experience With Topical Acne Treatment

NCT05582434 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB00089304
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Gender specific adherence (female subjects)

  End of study visit - day 56

• Gender specific adherence (male subjects)

  End of study visit - day 56

Study Arms (3)

One single fixed-combination product

EXPERIMENTAL

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

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

Two products

EXPERIMENTAL

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

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

Three products

EXPERIMENTAL

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

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

Interventions

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

Three topical treatments to be applied to area affected once daily.

Also known as: Differin®, Epsolay, Clindamycin

Three products

clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel DRUG

Single topical treatment to be applied daily to area affected once daily.

Also known as: Cabtreo®

One single fixed-combination product

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

Two topical treatments to be applied to area affected once daily.

Also known as: Epiduo® Forte and Clindamycin

Two products

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥18 years of age
• Patients with a current diagnosis of acne
• Patients who live in the US,
• Patients have sufficient command of the English language

You may not qualify if:

• Patients less than the age of 18
• Patients without a current diagnosis of acne
• Patients who do not live in the US
• Patients without a sufficient command of the English language

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related 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.

  PMID: 20618564 BACKGROUND

• 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.

  PMID: 27784999 BACKGROUND

• 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.

  PMID: 23572294 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Adapalene; Gels; Clindamycin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: February 15, 2024
• Primary Completion: June 19, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)