Back to resultsDose Range Study of CD5789 in Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CD5789 25 µg/g cream
CD5789 50 µg/g cream
CD5789 100 µg/g cream
Tazarotene 0.1% gel
Vehicle cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
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.
Sites / Locations
- Total Skin and Beauty Dermatology Center, PC
- Parexel Early Phase
- Odyssey Medispa
- Rady Children's Hospital
- FXM Research Corp Miami
- FMX Research Miramar
- Meda Phase, Inc
- Deaconess Clinic, Inc.
- Dermatology Specialists PC
- Hamzavi Dermatology
- Somerset Skin Centre
- Skin Specialists, PC
- Academic Dermatology Associates
- Zoe Drealos, MD
- PMG Research of Wilmington
- Central Sooner Research
- Oregon Dermatology and Research Center
- Palmetto Clinical Trial Services, LLC
- Arlington Center for Dermatology
- Suzanne Bruce and Associates P.A. The Center for Skin Research
- Stephen Miller MD
- Center for Clinical Studies
- Dermatology Research Center
- The Education & Research Foundation, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Experimental
Arm Label
CD5789 25 mcg/g Cream
CD5789 50 mcg/g Cream
CD5789 100 mcg/g Cream
Tazarotene 0.1% Gel
Vehicle Cream
Arm Description
Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
Percentage of Participants With Success Rate 2 (SR2)
Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to 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 LOCF.
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01616654
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2012 (Actual)
Primary Completion Date
July 24, 2013 (Actual)
Study Completion Date
June 12, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD5789 25 mcg/g Cream
Arm Type
Experimental
Arm Description
Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
Arm Title
CD5789 50 mcg/g Cream
Arm Type
Experimental
Arm Description
Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
Arm Title
CD5789 100 mcg/g Cream
Arm Type
Active Comparator
Arm Description
Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
Arm Title
Tazarotene 0.1% Gel
Arm Type
Placebo Comparator
Arm Description
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
Arm Title
Vehicle Cream
Arm Type
Experimental
Arm Description
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
CD5789 25 µg/g cream
Intervention Description
CD5789 25 µg/g cream applied once daily
Intervention Type
Drug
Intervention Name(s)
CD5789 50 µg/g cream
Intervention Description
CD5789 50 µg/g cream applied once daily
Intervention Type
Drug
Intervention Name(s)
CD5789 100 µg/g cream
Intervention Description
CD5789 100 µg/g cream applied once daily
Intervention Type
Drug
Intervention Name(s)
Tazarotene 0.1% gel
Intervention Description
Tazarotene 0.1% gel applied once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle cream applied once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Success Rate 1 (SR1)
Description
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).
Time Frame
From Baseline at Week 12
Title
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline, Week 12
Title
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Success Rate 2 (SR2)
Description
Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to 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 LOCF.
Time Frame
From Baseline to Week 12
Title
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Description
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.
Time Frame
Baseline, Week 12
Title
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Description
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, M.D.
Organizational Affiliation
Galderma R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Parexel Early Phase
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Odyssey Medispa
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
FXM Research Corp Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
FMX Research Miramar
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Meda Phase, Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Dermatology Specialists PC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Zoe Drealos, MD
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Suzanne Bruce and Associates P.A. The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Stephen Miller MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
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Dose Range Study of CD5789 in Acne Vulgaris
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