Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

NCT01951417 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SRE.04.US10268
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Total Lesion Count

  The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.

  Baseline, 2, 4, and 8 weeks

Secondary Outcomes (3)

• Inflammatory Lesions

  Baseline, 2, 4, and 8 weeks

• Non-inflammatory Lesions

  Baseline, 2, 4, and 8 weeks

• Subject Questionnaire

  Baseline, 2, 4, and 8 weeks

Other Outcomes (4)

• Erythema

  Baseline, 2, 4, and 8 weeks

• Scaling

  Baseline, 2, 4, and 8 weeks

• Dryness

  Baseline, 2, 4, and 8 weeks

Study Arms (1)

Adapalene/BPO Gel/Foam Wash/Moisturizer

EXPERIMENTAL

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Drug: Adapalene/BPO Gel; Other: Moisturizer SPF 30; Other: Foam Wash

Interventions

Adapalene/BPO Gel DRUG

Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Also known as: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump, Adapalene and benzoyl peroxide (BPO) gel

Adapalene/BPO Gel/Foam Wash/Moisturizer

Moisturizer SPF 30 OTHER

Moisturizer SPF 30 (once daily)

Also known as: Cetaphil® DermaControl™ Moisturizer SPF 30

Adapalene/BPO Gel/Foam Wash/Moisturizer

Foam Wash OTHER

Foam Wash (twice daily)

Also known as: Cetaphil® DermaControl™ Foam Wash

Adapalene/BPO Gel/Foam Wash/Moisturizer

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

You may not qualify if:

• \- Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (5)

Study Protocol, Inc.

Boynton Beach, Florida, 33437, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Stephens & Associates

Carrollton, Texas, 75006, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

The Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug Combination; Adapalene; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Limitations and Caveats

* Open label study with small sample size * Short study duration

Results Point of Contact

• Title: Elizabeth M Nieman
• Organization: Galderma Labratories, L.P.

elizabeth.nieman@galderma.com

817-961-5130

Study Officials

• Joshua M Berlin, MD

  Dermatology Associates, PA, of the Palm Beaches

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 23, 2022
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

US (5)