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Experience With Topical Acne Treatment

NCT ID: NCT05582434

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One single fixed-combination product

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Two products

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Three products

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Other Intervention Names

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Cabtreo® Epiduo® Forte and Clindamycin Differin®, Epsolay, Clindamycin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20618564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27784999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23572294 (View on PubMed)

Other Identifiers

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IRB00089304

Identifier Type: -

Identifier Source: org_study_id