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Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

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ClinicalTrials.gov Identifier: NCT02073461
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : November 3, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CD1579 2.5% Drug: CD1579 5% Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD1579 2.5%
Benzoyl Peroxide 2.5%
 Drug: CD1579 2.5%
Other Name: Benzoyl Peroxide 2.5%
Experimental: CD1579 5%
Benzoyl Peroxide 5%
 Drug: CD1579 5%
Other Name: Benzoyl Peroxide 5%
Placebo Comparator: Vehicle
Vehicle
 Drug: Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week 12 ]
    Median percent reductions from Baseline in total lesion count (ITT-LOCF)


Secondary Outcome Measures :
  1. Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
    Adverse events which were observed in 5% or more patients with either group are listed.

  2. Local Tolerability (Erythema) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  3. Local Tolerability (Scaling) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  4. Local Tolerability (Dryness) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  5. Local Tolerability (Pruritus) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  6. Local Tolerability (Stinging/Burning) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women at the age of 12 or older at the Screening visit.
  • Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

  • Those with more than two nodular acne lesions or any cysts.
  • Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
  • Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Contacts and Locations
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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): NCT02073461


Locations
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Japan
Galderma investigational site
Amagasaki, Hyogo, Japan
Galderma investigational site
Kobe, Hyogo, Japan
Galderma investigational site
Nakano, Tokyo, Japan
Galderma investigational site
Shibuya, Tokyo, Japan
Galderma investigational site
Shinjuku, Tokyo, Japan
Galderma investigational site
Fukuoka, Japan
Sponsors and Collaborators
Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02073461    
Other Study ID Numbers: RDT.07.SPR.27124
First Posted: February 27, 2014    Key Record Dates
Results First Posted: November 3, 2016
Last Update Posted: March 28, 2017
Last Verified: February 2017
Keywords provided by Galderma R&D:
Acne Vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents