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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522456
• Other study ID #: US10201
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: August 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Epiduo Gel
Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
• 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.

Locations

Country	Name	City	State
United States	Stephens and Associates	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Overall Tolerability Preference Survey	Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.	Day 22
Primary	Worst Postbaseline Tolerability (Erythema)	Worst postbaseline tolerability assessment for erythema.	Day 1 - Day 22
Primary	Worst Postbaseline Tolerability (Scaling)	Worst postbaseline assessment for scaling.	Day 1 - Day 22
Primary	Worst Postbaseline Tolerability (Dryness)	Worst postbaseline tolerability assessments for dryness.	Day 1 - Day 22
Primary	Worst Postbaseline Tolerability (Stinging/Burning)	Worst postbaseline tolerability assessments for stinging/burning	Day 1 - Day 22
Secondary	Tolerability at Day 22 (Erythema)	Tolerability assessments at day 22 for erythema	Day 22
Secondary	Tolerability at Day 22 (Dryness)	Tolerability assessments at day 22 for dryness	Day 22
Secondary	Tolerability at Day 22 (Scaling)	Tolerability assessments at day 22 for scaling	Day 22
Secondary	Tolerability at Day 22 (Stinging/Burning)	Tolerability assessments at day 22 for stinging/burning	Day 22
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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