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
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT01320033
- Lead Sponsor
- Galderma R&D
- Brief Summary
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
Investigator's global assessment and lesion count will be performed at each study visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 662
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD2475/101 40 mg Placebo Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. Doxycycline 100 mg Doxycycline 100 mg Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. Placebo Placebo Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks. CD2475/101 40 mg CD2475/101 40 mg Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. Doxycycline 100 mg Placebo Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) From Baseline up to Week 16 (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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) From Baseline up to Week 16 (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
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 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.
Number of Participants With at Least One Adverse Event (AE) From Baseline up to Week 16 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.
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) Week 16 (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).
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) From Baseline up to Week 16 (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.
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) From Baseline up to Week 16 (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.
Trial Locations
- Locations (31)
Haber Dermatology & cosmetic Surgery, Inc
🇺🇸South Euclid, Ohio, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Stephen Schleicher
🇺🇸Hazleton, Pennsylvania, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Central Dermatology, PC
🇺🇸Saint Louis, Missouri, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Arlington Center for Dermatology
🇺🇸Arlington, Texas, United States
Dermatology Research Associates, Inc.
🇺🇸Los Angeles, California, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
Grekin Skin Care
🇺🇸Warren, Michigan, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Suzanne Bruce and associates P.A. The Center for skin Research
🇺🇸Houston, Texas, United States
Dermatology Research Center
🇺🇸Salt Lake City, Utah, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Stephen Miller MD
🇺🇸San Antonio, Texas, United States
J&S Studies
🇺🇸College Station, Texas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Somerset Skin Care Center
🇺🇸Troy, Michigan, United States
Helendale Dermatology & Medical Spa
🇺🇸Rochester, New York, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Greenville, South Carolina, United States
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States
Dermatology Specialists PC
🇺🇸Louisville, Kentucky, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Academic Dermatology
🇺🇸Albuquerque, New Mexico, United States
Oregon Dermatology & Research Center
🇺🇸Portland, Oregon, United States
Derm Research, Inc
🇺🇸Austin, Texas, United States