Clinical trial NCT01320033: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne vulgaris
inflammatory lesions
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 662
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline up to Week 16 (LOCF)
Secondary outcomes:
measure: Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
timeFrame: Week 16 (LOCF)
measure: Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline up to Week 16 (LOCF)
measure: Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline up to Week 16 (LOCF)
measure: Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline up to Week 16 (LOCF)
measure: Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
timeFrame: Baseline, Week 12, and Week 16
measure: Number of Participants With at Least One Adverse Event (AE)
timeFrame: From Baseline up to Week 16
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates, Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists PC
state: Kentucky
city: Troy
country: United States
facility: Somerset Skin Care Center
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Care
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology
state: New Mexico
city: Rochester
country: United States
facility: Helendale Dermatology & Medical Spa
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: South Euclid
country: United States
facility: Haber Dermatology & cosmetic Surgery, Inc
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Hazleton
country: United States
facility: Stephen Schleicher
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Austin
country: United States
facility: Derm Research, Inc
state: Texas
city: College Station
country: United States
facility: J&S Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and associates P.A. The Center for skin Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller MD
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References: