Dose Range Study of CD5789 in Acne Vulgaris
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
1 other identifier
interventional
304
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2012
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedStudy Start
First participant enrolled
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2014
CompletedResults Posted
Study results publicly available
September 20, 2021
CompletedSeptember 20, 2021
August 1, 2021
1.1 years
June 8, 2012
August 23, 2021
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Success Rate 1 (SR1)
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
From Baseline at Week 12
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Baseline, Week 12
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Baseline, Week 12
Secondary Outcomes (3)
Percentage of Participants With Success Rate 2 (SR2)
From Baseline to Week 12
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Baseline, Week 12
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Baseline, Week 12
Study Arms (5)
CD5789 25 mcg/g Cream
EXPERIMENTALParticipants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
CD5789 50 mcg/g Cream
EXPERIMENTALParticipants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
CD5789 100 mcg/g Cream
ACTIVE COMPARATORParticipants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
Tazarotene 0.1% Gel
PLACEBO COMPARATORParticipants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
Vehicle Cream
EXPERIMENTALParticipants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (24)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
Parexel Early Phase
Glendale, California, 91206, United States
Odyssey Medispa
Marina del Rey, California, 90292, United States
Rady Children's Hospital
San Diego, California, 92123, United States
FXM Research Corp Miami
Miami, Florida, 33175, United States
FMX Research Miramar
Miramar, Florida, 33027, United States
Meda Phase, Inc
Newnan, Georgia, 30263, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
Dermatology Specialists PC
Louisville, Kentucky, 40202, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Zoe Drealos, MD
High Point, North Carolina, 27262, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Central Sooner Research
Norman, Oklahoma, 73069, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607, United States
Arlington Center for Dermatology
Arlington, Texas, 76011, United States
Suzanne Bruce and Associates P.A. The Center for Skin Research
Houston, Texas, 77056, United States
Stephen Miller MD
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Research Center
Salt Lake City, Utah, 84124, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Galderma
Study Officials
- STUDY DIRECTOR
Michael Graeber, M.D.
Galderma R&D, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
June 20, 2012
Primary Completion
July 24, 2013
Study Completion
June 12, 2014
Last Updated
September 20, 2021
Results First Posted
September 20, 2021
Record last verified: 2021-08