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Completed

NCT Number: NCT01951417

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

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Study Protocol, Inc., Boynton Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Adapalene/BPO Gel

Drug

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

Other names: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump, Adapalene and benzoyl peroxide (BPO) gel

Moisturizer SPF 30

Other

Moisturizer SPF 30 (once daily)

Other names: Cetaphil® DermaControl™ Moisturizer SPF 30

Foam Wash

Other

Foam Wash (twice daily)

Other names: Cetaphil® DermaControl™ Foam Wash

Primary outcomes

  1. Total Lesion Count

    Time frame: Baseline, 2, 4, and 8 weeks

    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.

Secondary outcomes

  1. Inflammatory Lesions

    Time frame: Baseline, 2, 4, and 8 weeks

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

  2. Non-inflammatory Lesions

    Time frame: Baseline, 2, 4, and 8 weeks

    The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks

  3. Subject Questionnaire

    Time frame: Baseline, 2, 4, and 8 weeks

    Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

Other outcomes

  1. Erythema

    Time frame: Baseline, 2, 4, and 8 weeks

    Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

  2. Scaling

    Time frame: Baseline, 2, 4, and 8 weeks

    Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

  3. Dryness

    Time frame: Baseline, 2, 4, and 8 weeks

    Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

  4. Stinging/Burning

    Time frame: Baseline, 2, 4, and 8 weeks

    Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2013
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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