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 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

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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

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

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


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

Additional relevant MeSH terms:


Adapalene, Benzoyl Peroxide Drug Combination Adapalene Benzoyl Peroxide 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 Dermatologic Agents

ClinicalTrials.gov processed this record on June 28, 2017