Split-face Tolerability Comparison Between Adapalene-BPO 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: June 13, 2012
Last verified: June 2012
  Purpose

To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere, 0.1% in subjects with acne vulgaris treated once daily for three (3) weeks.


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 post-baseline tolerability assessment [ Time Frame: Day 1 - Day 22 ] [ Designated as safety issue: Yes ]
    Worst post-baseline assessment for each of erythema, dryness, stinging/burning, and scaling.


Secondary Outcome Measures:
  • Tolerability assessments at day 22 [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]
    Erythema, scaling, dryness, and stinging/burning assessments at day 22

  • Cumulative tolerability assessments [ Time Frame: Baseline - Day 22 ] [ Designated as safety issue: Yes ]
    Cumulative assessments for each of erythema, dryness, scaling, stinging/burning from baseline through 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
Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Drug: Epiduo Gel
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%
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 of 22 days. Tolerability assessments on both sides of the face will be taken on each visit, which will be each weekday from baseline through day 22.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is diagnosed with acne vulgaris
  • For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 30 days prior to study entry.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing or planning a pregnancy during the study.
  • Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
  • Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications.
  • Subject has a known allergy to any of the components of the study products.
  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

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01522456     History of Changes
Other Study ID Numbers: US10201
Study First Received: January 23, 2012
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014