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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Epiduo Gel; Drug: Retin-A Micro Microsphere 0.1%

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75006
      • Stephens and Associates

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Postbaseline Tolerability (Erythema)	Worst postbaseline tolerability assessment for erythema.	Day 1 - Day 22
Worst Postbaseline Tolerability (Scaling)	Worst postbaseline assessment for scaling.	Day 1 - Day 22
Worst Postbaseline Tolerability (Dryness)	Worst postbaseline tolerability assessments for dryness.	Day 1 - Day 22
Worst Postbaseline Tolerability (Stinging/Burning)	Worst postbaseline tolerability assessments for stinging/burning	Day 1 - Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability at Day 22 (Erythema)	Tolerability assessments at day 22 for erythema	Day 22
Tolerability at Day 22 (Dryness)	Tolerability assessments at day 22 for dryness	Day 22
Tolerability at Day 22 (Scaling)	Tolerability assessments at day 22 for scaling	Day 22
Tolerability at Day 22 (Stinging/Burning)	Tolerability assessments at day 22 for stinging/burning	Day 22
Cumulative Tolerability (Erythema)	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.	Day 1 - Day 22
Cumulative Tolerability (Scaling)	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.	Day 1 - Day 22
Cumulative Tolerability (Dryness)	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.	Day 1 - Day 22
Cumulative Tolerability (Stinging/Burning)	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.	Day 1 - Day 22
Cumulative Tolerability (Combined)	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.	Day 1 - Day 22

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Ronald Gottschalk, MD, Galderma R&D

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: US10201