Dose Range Study of CD5789 in Acne Vulgaris

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	304 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	June 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Success Rate (IGA) [ Time Frame: up to Week 12 ]
   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.
2. Absolute change in total lesion counts [ Time Frame: Baseline to Week 12 ]
   Absolute change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.
3. Percent Change in total lesion counts [ Time Frame: Baseline to Week 12 ]
   Percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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  Show 24 Study Locations

Sponsors and Collaborators

Galderma

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT01616654 History of Changes
Other Study ID Numbers:	RD.06.SPR18223
First Posted:	June 12, 2012
Last Update Posted:	February 11, 2014
Last Verified:	January 2014

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