Dose Range Study of CD5789 in Acne Vulgaris

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616654
• Other study ID #: RD.06.SPR.18223
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2012
• Est. completion date: June 12, 2014

Study information

• Verified date: August 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 12, 2014
• Est. primary completion date: July 24, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CD5789 25 µg/g cream
CD5789 25 µg/g cream applied once daily
• CD5789 50 µg/g cream
CD5789 50 µg/g cream applied once daily
• CD5789 100 µg/g cream
CD5789 100 µg/g cream applied once daily
• Tazarotene 0.1% gel
Tazarotene 0.1% gel applied once daily
• Vehicle cream
Vehicle cream applied once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	From Baseline to Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12