Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris

Study Overview
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Brief Summary
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The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.

Detailed Description
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Investigator's global assessment and lesion count will be performed at each study visit.

Official Title
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A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CD2475/101 40 mg
* Drug: Doxycycline 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 12 years of age or older acne vulgaris with facial involvement A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory) 25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose) Exclusion Criteria: More than two acne nodules/cysts on the face Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea Beard or facial hair which might interfere with study assessments planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp) Use of oral contraceptives solely for control of acne Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis Females who intend to conceive a child within 5 months following Baseline visit Males who intend to conceive a child with partner during the study period Requiring concomitant use of methoxyflurane

Ages Eligible for Study
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Minimum Age: 12 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: CD2475/101 40 mg<br>Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. | Drug: CD2475/101 40 mg<br>* Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.<br>Drug: Placebo<br>* Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.<br>|
| Active Comparator: Doxycycline 100 mg<br>Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. | Drug: Doxycycline 100 mg<br>* Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks<br>Drug: Placebo<br>* Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.<br>|
| Placebo Comparator: Placebo<br>Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks. | Drug: Placebo<br>* Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | From Baseline up to Week 16 (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) | IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF). | Week 16 (LOCF) | 
| Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | From Baseline up to Week 16 (LOCF) | 
| Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported. | From Baseline up to Week 16 (LOCF) | 
| Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | 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). Change from baseline in non-inflammatory lesion counts to week 16 were reported | From Baseline up to Week 16 (LOCF) | 
| Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 | Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions. | Baseline, Week 12, and Week 16 | 
| Number of Participants With at Least One Adverse Event (AE) | An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported. | From Baseline up to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, inflammatory lesions