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Trial record 73 of 134 for:    acne AND peroxide

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

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ClinicalTrials.gov Identifier: NCT01951417
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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.

Condition or disease Intervention/treatment Phase
Acne Drug: Adapalene/BPO Gel Other: Moisturizer SPF 30 Other: Foam Wash Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Adapalene/BPO Gel/Foam Wash/Moisturizer
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Drug: Adapalene/BPO Gel
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

Other: Moisturizer SPF 30
Moisturizer SPF 30 (once daily)
Other Name: Cetaphil® DermaControl™ Moisturizer SPF 30

Other: Foam Wash
Foam Wash (twice daily)
Other Name: Cetaphil® DermaControl™ Foam Wash




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951417


Locations
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United States, Florida
Study Protocol, Inc.
Boynton Beach, Florida, United States, 33437
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Stephens & Associates
Carrolton, Texas, United States, 75006
J&S Studies, Inc.
College Station, Texas, United States, 77845
The Dermatology Clinical Research Center of San Antonio
San Antoinio, Texas, United States, 78229
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Principal Investigator: Joshua M Berlin, MD Dermatology Associates, PA, of the Palm Beaches

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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01951417     History of Changes
Other Study ID Numbers: GLI.04.SRE.04.US10268
First Posted: September 26, 2013    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Acne Vulgaris
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents