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 |
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Recruitment Status :
Completed
First Posted : September 26, 2013
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
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Sponsor:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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)
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Drug: Adapalene/BPO Gel
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Other Names:
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 :
- 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 :
- 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.
- 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
- 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:
- 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.
- 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.
- 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.
- 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
| 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
| Principal Investigator: | Joshua M Berlin, MD | Dermatology Associates, PA, of the Palm Beaches |
| 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 |