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Dose Range Study of CD5789 in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01616654
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2012
Actual Primary Completion Date : July 24, 2013
Actual Study Completion Date : June 12, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




Primary Outcome Measures :
  1. Percentage of Participants With Success Rate 1 (SR1) [ Time Frame: 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).

  2. Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) [ Time Frame: 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.

  3. Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) [ Time Frame: 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 :
  1. Percentage of Participants With Success Rate 2 (SR2) [ Time Frame: 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.

  2. Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) [ Time Frame: 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.

  3. Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616654


Locations
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Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Michael Graeber, M.D. Galderma R&D, Inc.
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01616654    
Other Study ID Numbers: RD.06.SPR.18223
First Posted: June 12, 2012    Key Record Dates
Results First Posted: September 20, 2021
Last Update Posted: September 20, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Trifarotene
Dermatologic Agents
Keratolytic Agents