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Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00671749
First received: April 30, 2008
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Condition Intervention Phase
Acne Vulgaris
Drug: adapalene gel, 0.3%
Drug: clindamycin/benzoyl peroxide gel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change From Baseline in Total Lesion Counts [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Severity Assessment Success [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear

  • Global Assessment of Improvement From Baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Worst Post Baseline Tolerability Assessment - Erythema [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  • Worst Post Baseline Tolerability Assessment - Scaling [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  • Worst Post Baseline Tolerability Assessment - Dryness [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  • Worst Post Baseline Tolerability Assessment - Burning/Stinging [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.


Enrollment: 100
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Treatment

adapalene gel, 0.3%

Other Names:

Differin® Gel, 0.3% Applied once daily at bedtime

clindamycin/benzoyl peroxide gel

Other Names:

Duac® Gel Applied once daily in the morning

Drug: adapalene gel, 0.3%
Applied once daily at bedtime
Other Name: Differin® Gel, 0.3%
Drug: clindamycin/benzoyl peroxide gel
Applied once daily in the morning
Other Name: Duac® Gel

Detailed Description:
Same as above.
  Eligibility

Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with a minimum of 20 inflammatory lesions on the face;
  2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
  3. Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

  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: NCT00671749

Locations
United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Kentucky
Derm Research, P.L.L.C.
Louisville, Kentucky, United States, 40217
United States, Ohio
Brodell Medical
Warren, Ohio, United States, 44483
United States, Oregon
Northwest Cutaneous Research Specialists
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ron W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00671749     History of Changes
Other Study ID Numbers: US10066 
Study First Received: April 30, 2008
Results First Received: August 12, 2014
Last Updated: February 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Adapalene
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 26, 2016