Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel

• ClinicalTrials.gov Identifier: NCT01522456
• Recruitment Status: Completed
• First Posted: January 31, 2012
• Results First Posted: August 18, 2015
• Last Update Posted: August 18, 2015
• Sponsor: Galderma Laboratories, L.P.
• Information provided by (Responsible Party): Galderma Laboratories, L.P.

Study Description

Brief Summary:

To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Epiduo Gel; Drug: Retin-A Micro Microsphere 0.1%	Phase 4

Detailed Description:

Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris
• Study Start Date: April 2012
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Epiduo Gel; Adapalene 0.1% and benzoyl peroxide 2.5% gel	Drug: Epiduo Gel; Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
Active Comparator: Retin-A Micro Microsphere 0.1%; Tretinoin gel, 0.1%	Drug: Retin-A Micro Microsphere 0.1%; Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Outcome Measures

Primary Outcome Measures :

1. Worst Postbaseline Tolerability (Erythema) [ Time Frame: Day 1 - Day 22 ]
   Worst postbaseline tolerability assessment for erythema.
2. Worst Postbaseline Tolerability (Scaling) [ Time Frame: Day 1 - Day 22 ]
   Worst postbaseline assessment for scaling.
3. Worst Postbaseline Tolerability (Dryness) [ Time Frame: Day 1 - Day 22 ]
   Worst postbaseline tolerability assessments for dryness.
4. Worst Postbaseline Tolerability (Stinging/Burning) [ Time Frame: Day 1 - Day 22 ]
   Worst postbaseline tolerability assessments for stinging/burning

Secondary Outcome Measures :

1. Tolerability at Day 22 (Erythema) [ Time Frame: Day 22 ]
   Tolerability assessments at day 22 for erythema
2. Tolerability at Day 22 (Dryness) [ Time Frame: Day 22 ]
   Tolerability assessments at day 22 for dryness
3. Tolerability at Day 22 (Scaling) [ Time Frame: Day 22 ]
   Tolerability assessments at day 22 for scaling
4. Tolerability at Day 22 (Stinging/Burning) [ Time Frame: Day 22 ]
   Tolerability assessments at day 22 for stinging/burning
5. Cumulative Tolerability (Erythema) [ Time Frame: Day 1 - Day 22 ]
   Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
6. Cumulative Tolerability (Scaling) [ Time Frame: Day 1 - Day 22 ]
   Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
7. Cumulative Tolerability (Dryness) [ Time Frame: Day 1 - Day 22 ]
   Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
8. Cumulative Tolerability (Stinging/Burning) [ Time Frame: Day 1 - Day 22 ]
   Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.
9. Cumulative Tolerability (Combined) [ Time Frame: Day 1 - Day 22 ]
   Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

Other Outcome Measures:

1. User Preference Survey (Investigator) [ Time Frame: Day 5, day 12, day 19, and day 22 ]
   Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants.
2. User Preference Survey (Subjects) [ Time Frame: Day 5, day 12, day 19, and day 22 ]
   Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.
3. Overall Tolerability Preference Survey [ Time Frame: Day 22 ]
   Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male and female subjects of any race
• Subjects 18 years or older
• Subjects with acne vulgaris

Exclusion Criteria:

• Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
• Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
• Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
• Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
• Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)

Contacts and Locations

Locations

United States, Texas

Stephens and Associates

Dallas, Texas, United States, 75006

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

• Study Director: Ronald Gottschalk, MD; Galderma Laboratories, L.P.

More Information

• Responsible Party: Galderma Laboratories, L.P.
• ClinicalTrials.gov Identifier: NCT01522456
• Other Study ID Numbers: US10201
• First Posted: January 31, 2012
• Results First Posted: August 18, 2015
• Last Update Posted: August 18, 2015
• Last Verified: August 2015

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Tretinoin; Dermatologic Agents; Antineoplastic Agents; Keratolytic Agents