ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Range Study of CD5789 in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


  Show 24 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, M.D. Galderma R&D, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Nicotinic Acids
Dermatologic Agents
 Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs