Clinical trial NCT01616654: Dose Range Study of CD5789 in Acne Vulgaris
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 304
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Male or female participant, 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: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

    * Note: Participants 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 participant at significant risk (according to the Investigator's judgment) if the participant 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.

Primary outcomes:
measure: Percentage of Participants With Success Rate 1 (SR1)
timeFrame: From Baseline at Week 12
measure: Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With Success Rate 2 (SR2)
timeFrame: From Baseline to Week 12
measure: Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Glendale
country: United States
facility: Parexel Early Phase
state: California
city: Marina Del Rey
country: United States
facility: Odyssey Medispa
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Miami
country: United States
facility: FXM Research Corp Miami
state: Florida
city: Miramar
country: United States
facility: FMX Research Miramar
state: Florida
city: Newnan
country: United States
facility: Meda Phase, Inc
state: Georgia
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists PC
state: Kentucky
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: High Point
country: United States
facility: Zoe Drealos, MD
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates P.A. The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller MD
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Galderma R&D, Inc.
name: Michael Graeber, M.D.
role: STUDY_DIRECTOR
References: