Dose Range Study of CD5789 in Acne Vulgaris - Full Text View

Purpose

To assess the efficacy and safety of different concentrations of CD5789 cream in subjects with acne vulgaris for the purpose of dose identification.

Condition	Intervention	Phase
Acne Vulgaris	Drug: CD5789 25 µg/g cream Drug: CD5789 50 µg/g cream Drug: CD5789 100 µg/g cream Drug: Tazarotene 0.1% gel Drug: Vehicle cream	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Tazarotene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Success Rate (IGA) [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
Defined as the percentage of subjects who achieve at least a two-point reduction in the IGA score from Baseline at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat (ITT) population.
Absolute change in total lesion counts [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Absolute change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.
Percent Change in total lesion counts [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules


Enrollment:	304
Study Start Date:	June 2012
Study Completion Date:	September 2013
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD5789 50 µg/g cream CD5789 50 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3	Drug: CD5789 50 µg/g cream CD5789 50 µg/g cream applied once daily
Experimental: CD5789 100 µg/g cream CD5789 100 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3	Drug: CD5789 100 µg/g cream CD5789 100 µg/g cream applied once daily
Active Comparator: Tazarotene 0.1% gel Tazarotene 0.1% gel applied once daily for subjects randomized in Stratum 1 and 2	Drug: Tazarotene 0.1% gel Tazarotene 0.1% gel applied once daily
Placebo Comparator: Vehicle cream Vehicle cream applied once daily for subjects randomized in Stratum 1, 2 and 3	Drug: Vehicle cream Vehicle cream applied once daily
Experimental: CD5789 25 µg/g cream CD5789 25 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3	Drug: CD5789 25 µg/g cream CD5789 25 µg/g cream applied once daily

Eligibility


Ages Eligible for Study:	12 Years to 35 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subject, 12 to 35 years old with the following characteristics:
Facial acne severity grade of the following:
- Stratum 1: IGA score of 3 or 4
- Stratum 2: IGA score of 4
- Stratum 3: IGA score of 3 or 4
A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:
- Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
- Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
- Stratum 3: Subjects of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
  - Note: Subjects of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Exclusion Criteria:

The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject participates in the clinical trial.
Known or suspected allergies or sensitivities to any components of any of the study drugs.
Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

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: NCT01616654

Show 24 Study Locations

Sponsors and Collaborators

Galderma

Investigators


Study Director:	Michael Graeber, M.D.	Galderma R&D, Inc.

More Information


Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT01616654 History of Changes
Other Study ID Numbers:	RD.06.SPR18223
Study First Received:	June 8, 2012
Last Updated:	January 14, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Tazarotene Nicotinic Acids Dermatologic Agents	Keratolytic Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016