Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
This study has been completed.
Sponsor:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01209949
First received: September 24, 2010
Last updated: January 18, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris |
Resource links provided by NLM:
Further study details as provided by Galderma Laboratories, L.P.:
Primary Outcome Measures:
- Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Secondary Outcome Measures:
- Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
- Number of Participants With Tolerability Assessments Resulting in an Adverse Event [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
| Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% gel |
Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Apply adapalene BPO gel once daily in the evening for 12 weeks
Other Name: Epiduo® Gel
|
Eligibility| Ages Eligible for Study: | 16 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects, aged 16 to 25 years inclusive;
- Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
- A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
- Subjects who agree to be photographed at each visit;
- Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study
Exclusion Criteria:
- Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
- Subjects with a wash-out period for topical acne treatment on the face less than 30 days
- Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
- Subjects who are currently being treated with antibiotics;
- Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
- Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209949
Locations
| United States, Texas | |
| Thomas J. Stephens and Associates | |
| Carrollton, Texas, United States, 75006 | |
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
| Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, L.P. |
More Information
No publications provided
| Responsible Party: | Galderma Laboratories, L.P. |
| ClinicalTrials.gov Identifier: | NCT01209949 History of Changes |
| Other Study ID Numbers: | US10179 |
| Study First Received: | September 24, 2010 |
| Results First Received: | December 13, 2011 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
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 Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013