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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01106807
First received: April 19, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Total acne lesion count [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    change in total number of acne lesion count from baseline to end of treatment

  • Percent change of acne lesion count [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Percent change of acne lesion count from baseline to end of treatment


Secondary Outcome Measures:
  • Lesion counts- Inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  • Lesion count- non-inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  • Lesion counts- Inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Percent change of acne lesion count from baseline at each evaluation visit

  • Lesion count- non-inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Percent change of acne lesion count from baseline at each evaluation visit


Enrollment: 73
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01106807     History of Changes
Other Study ID Numbers: RD.06.SPR.18173
Study First Received: April 19, 2010
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014