Dose Range Study of CD5789 in Acne Vulgaris

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Tazarotene 0.1% gel
Drug: CD5789 50 µg/g cream
Drug: CD5789 25 µg/g cream
Drug: CD5789 100 µg/g cream
Drug: Vehicle cream

Registration Number: NCT01616654

Lead Sponsor: Galderma R&D

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 304

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tazarotene 0.1% Gel	Tazarotene 0.1% gel	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
CD5789 50 mcg/g Cream	CD5789 50 µg/g cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
CD5789 25 mcg/g Cream	CD5789 25 µg/g cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
CD5789 100 mcg/g Cream	CD5789 100 µg/g cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
Vehicle Cream	Vehicle cream	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Success Rate 1 (SR1)	From Baseline at Week 12	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).
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)	Baseline, Week 12	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.
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)	Baseline, Week 12	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

Name	Time	Method
Percentage of Participants With Success Rate 2 (SR2)	From Baseline to Week 12	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.
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)	Baseline, Week 12	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.
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)	Baseline, Week 12	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.

Trial Locations

Locations (24): Hamzavi Dermatology
🇺🇸
Fort Gratiot, Michigan, United States
Palmetto Clinical Trial Services, LLC
🇺🇸
Greenville, South Carolina, United States
Somerset Skin Centre
🇺🇸
Troy, Michigan, United States
Skin Specialists, PC
🇺🇸
Omaha, Nebraska, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸
Birmingham, Alabama, United States
FXM Research Corp Miami
🇺🇸
Miami, Florida, United States
FMX Research Miramar
🇺🇸
Miramar, Florida, United States
Odyssey Medispa
🇺🇸
Marina Del Rey, California, United States
Parexel Early Phase
🇺🇸
Glendale, California, United States
Rady Children's Hospital
🇺🇸
San Diego, California, United States
Deaconess Clinic, Inc.
🇺🇸
Evansville, Indiana, United States
Meda Phase, Inc
🇺🇸
Newnan, Georgia, United States
Dermatology Specialists PC
🇺🇸
Louisville, Kentucky, United States
Central Sooner Research
🇺🇸
Norman, Oklahoma, United States
PMG Research of Wilmington
🇺🇸
Wilmington, North Carolina, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Zoe Drealos, MD
🇺🇸
High Point, North Carolina, United States
Arlington Center for Dermatology
🇺🇸
Arlington, Texas, United States
Suzanne Bruce and Associates P.A. The Center for Skin Research
🇺🇸
Houston, Texas, United States
Stephen Miller MD
🇺🇸
San Antonio, Texas, United States
Center for Clinical Studies
🇺🇸
Webster, Texas, United States
The Education & Research Foundation, Inc.
🇺🇸
Lynchburg, Virginia, United States
Dermatology Research Center
🇺🇸
Salt Lake City, Utah, United States