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Completed

NCT Number: NCT01522456

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stephens and Associates

Dallas, Texas, 75006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epiduo Gel

Drug

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%

Drug

Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2012
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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