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
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
1 other identifier
interventional
662
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
March 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2012
CompletedResults Posted
Study results publicly available
February 10, 2020
CompletedFebruary 18, 2021
December 1, 2019
9 months
March 21, 2011
November 21, 2019
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
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)
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
From Baseline up to Week 16 (LOCF)
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
From Baseline up to Week 16 (LOCF)
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Baseline, Week 12, and Week 16
- +1 more secondary outcomes
Study Arms (3)
CD2475/101 40 mg
EXPERIMENTALParticipants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
Doxycycline 100 mg
ACTIVE COMPARATORParticipants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
Placebo
PLACEBO COMPARATORParticipants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- to 75 inflammatory lesions (papules and pustules) on the face (including the nose)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (31)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Dermatology Research Associates, Inc.
Los Angeles, California, 90045, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Dermatology Specialists PC
Louisville, Kentucky, 40202, United States
Somerset Skin Care Center
Troy, Michigan, 48084, United States
Grekin Skin Care
Warren, Michigan, 48088, United States
Central Dermatology, PC
St Louis, Missouri, 63117, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Academic Dermatology
Albuquerque, New Mexico, 87106, United States
Helendale Dermatology & Medical Spa
Rochester, New York, 14609, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Haber Dermatology & cosmetic Surgery, Inc
South Euclid, Ohio, 44118, United States
Central Sooner Research
Norman, Oklahoma, 73069, United States
Oregon Dermatology & Research Center
Portland, Oregon, 97210, United States
Stephen Schleicher
Hazleton, Pennsylvania, 18201, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Arlington Center for Dermatology
Arlington, Texas, 76011, United States
Derm Research, Inc
Austin, Texas, 78759, United States
J&S Studies
College Station, Texas, 77845, United States
Suzanne Bruce and associates P.A. The Center for skin Research
Houston, Texas, 77056, United States
Center for Clinical Studies
Houston, Texas, 77058, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Stephen Miller MD
San Antonio, Texas, 78229, United States
Dermatology Research Center
Salt Lake City, Utah, 84124, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Galderma
Study Officials
- STUDY DIRECTOR
Michael Graeber, MD
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 22, 2011
Study Start
March 29, 2011
Primary Completion
January 3, 2012
Study Completion
January 3, 2012
Last Updated
February 18, 2021
Results First Posted
February 10, 2020
Record last verified: 2019-12