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Dose Range Study of CD5789 in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01616654
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
To assess the efficacy and safety of different concentrations of CD5789 cream in subjects with acne vulgaris for the purpose of dose identification.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CD5789 25 µg/g cream Drug: CD5789 50 µg/g cream Drug: CD5789 100 µg/g cream Drug: Tazarotene 0.1% gel Drug: Vehicle cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris
Study Start Date : June 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: CD5789 50 µg/g cream
CD5789 50 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
Drug: CD5789 50 µg/g cream
CD5789 50 µg/g cream applied once daily

Experimental: CD5789 100 µg/g cream
CD5789 100 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
Drug: CD5789 100 µg/g cream
CD5789 100 µg/g cream applied once daily

Active Comparator: Tazarotene 0.1% gel
Tazarotene 0.1% gel applied once daily for subjects randomized in Stratum 1 and 2
Drug: Tazarotene 0.1% gel
Tazarotene 0.1% gel applied once daily

Placebo Comparator: Vehicle cream
Vehicle cream applied once daily for subjects randomized in Stratum 1, 2 and 3
Drug: Vehicle cream
Vehicle cream applied once daily

Experimental: CD5789 25 µg/g cream
CD5789 25 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
Drug: CD5789 25 µg/g cream
CD5789 25 µg/g cream applied once daily




Primary Outcome Measures :
  1. Success Rate (IGA) [ Time Frame: up to Week 12 ]
    Defined as the percentage of subjects who achieve at least a two-point reduction in the IGA score from Baseline at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat (ITT) population.

  2. Absolute change in total lesion counts [ Time Frame: Baseline to Week 12 ]
    Absolute change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.

  3. Percent Change in total lesion counts [ Time Frame: Baseline to Week 12 ]
    Percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules



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

Inclusion Criteria:

  • Male or female subject, 12 to 35 years old with the following characteristics:
  • Facial acne severity grade of the following:

    • Stratum 1: IGA score of 3 or 4
    • Stratum 2: IGA score of 4
    • Stratum 3: IGA score of 3 or 4
  • A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

    • Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
    • Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
    • Stratum 3: Subjects of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

      • Note: Subjects of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Exclusion Criteria:

  • The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
  • Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject participates in the clinical trial.
  • Known or suspected allergies or sensitivities to any components of any of the study drugs.
  • Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616654


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Locations
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United States, Alabama
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
United States, California
Parexel Early Phase
Glendale, California, United States, 91206
Odyssey Medispa
Marina Del Rey, California, United States, 90292
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Florida
FXM Research Corp Miami
Miami, Florida, United States, 33175
FMX Research Miramar
Miramar, Florida, United States, 33027
United States, Georgia
Meda Phase, Inc
Newnan, Georgia, United States, 30263
United States, Indiana
Deaconess Clinic, Inc.
Evansville, Indiana, United States, 47713
United States, Kentucky
Dermatology Specialists PC
Louisville, Kentucky, United States, 40202
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Zoe Drealos, MD
High Point, North Carolina, United States, 27262
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73069
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, South Carolina
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States, 29607
United States, Texas
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
Suzanne Bruce and Associates P.A. The Center for Skin Research
Houston, Texas, United States, 77056
Stephen Miller MD
San Antonio, Texas, United States, 78229
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Utah
Dermatology Research Center
Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Galderma
Investigators
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Study Director: Michael Graeber, M.D. Galderma R&D, Inc.

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01616654     History of Changes
Other Study ID Numbers: RD.06.SPR18223
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Tazarotene
Trifarotene
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs