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Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

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ClinicalTrials.gov Identifier: NCT01106807
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Description
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Brief Summary:
The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

Condition or disease Intervention/treatment Phase
Acne Drug: Epiduo vehicle gel Drug: CD07223 Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD07223 1.5% gel
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
 Drug: Epiduo vehicle gel
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

Drug: CD07223
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
Experimental: CD07223 0.5% gel
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
 Drug: Epiduo vehicle gel
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

Drug: CD07223
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
Active Comparator: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces
 Drug: Epiduo vehicle gel
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
500 microliters Epiduo Gel on one of the half-face for the morning dose


Outcome Measures
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Primary Outcome Measures :
  1. Total acne lesion count [ Time Frame: 6 weeks ]
    change in total number of acne lesion count from baseline to end of treatment

  2. Percent change of acne lesion count [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline to end of treatment


Secondary Outcome Measures :
  1. Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  2. Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  3. Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline at each evaluation visit

  4. Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline at each evaluation visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject has a clinical diagnosis of acne vulgaris with facial involvement
  • the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

  • subject has a severe acne form or secondary acne form
  • the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
  • the subject has a known allergy or sensitivity to any of the components of the study products
  • subject is not willing to respect wash-out periods for topical and/or systemic treatments
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): NCT01106807


Locations
United States, Arkansas
Burke Pharmaceuticals
Hot Springs, Arkansas, United States
United States, Kentucky
Dermatology Specialist PSC
Louisville, Kentucky, United States, 40202
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, New Jersey
TKL Research
Rochelle Park, New Jersey, United States, 07662
United States, North Carolina
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Cetero
Fargo, North Dakota, United States, 58104
United States, Texas
Derm Research, Inc
Austin, Texas, United States, 78759
J & S Studies
Bryan, Texas, United States, 77845
United States, Virginia
Education and Research Foundation, Inc
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
More Information
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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01106807     History of Changes
Other Study ID Numbers: RD.06.SPR.18173
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
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