Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne - Full Text View

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:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

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

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 May 23, 2013