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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CD5789 25 µg/g cream; Drug: CD5789 50 µg/g cream; Drug: CD5789 100 µg/g cream; Drug: Tazarotene 0.1% gel; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • California
    • Glendale, California, United States, 91206
      • Parexel Early Phase
    • Marina Del Rey, California, United States, 90292
      • Odyssey Medispa
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Florida
    • Miami, Florida, United States, 33175
      • FXM Research Corp Miami
    • Miramar, Florida, United States, 33027
      • FMX Research Miramar
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Meda Phase, Inc
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists PC
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Zoe Drealos, MD
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates P.A. The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Stephen Miller MD
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD5789 25 mcg/g Cream; Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 25 µg/g cream; CD5789 25 µg/g cream applied once daily
Experimental: CD5789 50 mcg/g Cream; Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.	Drug: CD5789 50 µg/g cream; CD5789 50 µg/g cream applied once daily
Active Comparator: CD5789 100 mcg/g Cream; Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 100 µg/g cream; CD5789 100 µg/g cream applied once daily
Placebo Comparator: Tazarotene 0.1% Gel; Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Drug: Tazarotene 0.1% gel; Tazarotene 0.1% gel applied once daily
Experimental: Vehicle Cream; Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.	Drug: Vehicle cream; Vehicle cream applied once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Michael Graeber, M.D., Galderma R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2012
• Primary Completion (Actual): July 24, 2013
• Study Completion (Actual): June 12, 2014

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 11, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Keratolytic Agents; Tazarotene; Trifarotene
• Other Study ID Numbers: RD.06.SPR.18223