Dose Range Study of CD5789 in Acne Vulgaris

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

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |