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.
Investigator's global assessment and lesion count will be performed at each study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
662
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
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.
Time frame: From Baseline up to Week 16 (LOCF)
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).
Time frame: 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.
Time frame: 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.
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Dermatology Research Associates, Inc.
Los Angeles, California, United States
Colorado Medical Research Center
Denver, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
International Dermatology Research, Inc.
Miami, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Dermatology Specialists PC
Louisville, Kentucky, United States
Somerset Skin Care Center
Troy, Michigan, United States
Grekin Skin Care
Warren, Michigan, United States
Central Dermatology, PC
St Louis, Missouri, United States
...and 21 more locations
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From Baseline up to Week 16