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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01522456
First received: January 23, 2012
Last updated: August 10, 2015
Last verified: August 2015
  Purpose
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 Intervention Phase
Acne Vulgaris
Drug: Epiduo Gel
Drug: Retin-A Micro Microsphere 0.1%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Worst Postbaseline Tolerability (Erythema) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    Worst postbaseline tolerability assessment for erythema.

  • Worst Postbaseline Tolerability (Scaling) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    Worst postbaseline assessment for scaling.

  • Worst Postbaseline Tolerability (Dryness) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    Worst postbaseline tolerability assessments for dryness.

  • Worst Postbaseline Tolerability (Stinging/Burning) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    Worst postbaseline tolerability assessments for stinging/burning


Secondary Outcome Measures:
  • Tolerability at Day 22 (Erythema) [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]
    Tolerability assessments at day 22 for erythema

  • Tolerability at Day 22 (Dryness) [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]
    Tolerability assessments at day 22 for dryness

  • Tolerability at Day 22 (Scaling) [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]
    Tolerability assessments at day 22 for scaling

  • Tolerability at Day 22 (Stinging/Burning) [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]
    Tolerability assessments at day 22 for stinging/burning

  • Cumulative Tolerability (Erythema) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    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.

  • Cumulative Tolerability (Scaling) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    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.

  • Cumulative Tolerability (Dryness) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    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.

  • Cumulative Tolerability (Stinging/Burning) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    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.

  • Cumulative Tolerability (Combined) [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    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:
  • User Preference Survey (Investigator) [ Time Frame: Day 5, day 12, day 19, and day 22 ] [ Designated as safety issue: No ]
    Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants.

  • User Preference Survey (Subjects) [ Time Frame: Day 5, day 12, day 19, and day 22 ] [ Designated as safety issue: No ]
    Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.

  • Overall Tolerability Preference Survey [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.


Enrollment: 73
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522456

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     History of Changes
Other Study ID Numbers: US10201 
Study First Received: January 23, 2012
Results First Received: March 11, 2013
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Adapalene
Benzoyl Peroxide
Tretinoin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Keratolytic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016