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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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CD2475/101 40 mg
Doxycycline 100 mg
Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, inflammatory lesions

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burke Pharmaceutical Research
  • Dermatology Research Associates, Inc.
  • Colorado Medical Research Center
  • Longmont Medical Research Network
  • International Dermatology Research, Inc.
  • MedaPhase, Inc.
  • Dermatology Specialists PC
  • Somerset Skin Care Center
  • Grekin Skin Care
  • Central Dermatology, PC
  • Skin Specialists, PC
  • Academic Dermatology
  • Helendale Dermatology & Medical Spa
  • Dermatology Consulting Services
  • PMG Research of Wilmington
  • Haber Dermatology & cosmetic Surgery, Inc
  • Central Sooner Research
  • Oregon Dermatology & Research Center
  • Stephen Schleicher
  • Palmetto Clinical Trial Services, LLC
  • Dermatology Research Associates
  • Tennessee Clinical Research Center
  • Arlington Center for Dermatology
  • Derm Research, Inc
  • J&S Studies
  • Suzanne Bruce and associates P.A. The Center for skin Research
  • Center for Clinical Studies
  • Progressive Clinical Research
  • Stephen Miller MD
  • Dermatology Research Center
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CD2475/101 40 mg

Doxycycline 100 mg

Placebo

Arm Description

Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.

Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.

Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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
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.
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.

Full Information

First Posted
March 21, 2011
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01320033
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2011 (Actual)
Primary Completion Date
January 3, 2012 (Actual)
Study Completion Date
January 3, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris, inflammatory lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
662 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD2475/101 40 mg
Arm Type
Experimental
Arm Description
Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
Arm Title
Doxycycline 100 mg
Arm Type
Active Comparator
Arm Description
Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
CD2475/101 40 mg
Intervention Description
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Doxycycline 100 mg
Intervention Description
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Description
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)
Secondary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
Description
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)
Title
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Description
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)
Title
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Description
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.
Time Frame
From Baseline up to Week 16 (LOCF)
Title
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Description
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)
Title
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Description
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
Title
Number of Participants With at Least One Adverse Event (AE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Dermatology Research Associates, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dermatology Specialists PC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Somerset Skin Care Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Grekin Skin Care
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Central Dermatology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Academic Dermatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Helendale Dermatology & Medical Spa
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Haber Dermatology & cosmetic Surgery, Inc
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Stephen Schleicher
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Derm Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Suzanne Bruce and associates P.A. The Center for skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Stephen Miller MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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