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Completed

NCT Number: NCT01616654

Dose Range Study of CD5789 in 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD5789 25 µg/g cream

Drug

CD5789 25 µg/g cream applied once daily

CD5789 50 µg/g cream

Drug

CD5789 50 µg/g cream applied once daily

CD5789 100 µg/g cream

Drug

CD5789 100 µg/g cream applied once daily

Tazarotene 0.1% gel

Drug

Tazarotene 0.1% gel applied once daily

Vehicle cream

Drug

Vehicle cream applied once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 12, 2012
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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