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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CD2475/101 40 mg; Drug: Placebo; Drug: Doxycycline 100 mg

Detailed Description

Investigator's global assessment and lesion count will be performed at each study visit.

• Study Type: Interventional
• Enrollment (Actual): 662
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates, Inc.
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
    • Longmont, Colorado, United States, 80501
      • Longmont Medical Research Network
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists PC
  • Michigan
    • Troy, Michigan, United States, 48084
      • Somerset Skin Care Center
    • Warren, Michigan, United States, 48088
      • Grekin Skin Care
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology
  • New York
    • Rochester, New York, United States, 14609
      • Helendale Dermatology & Medical Spa
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • South Euclid, Ohio, United States, 44118
      • Haber Dermatology & cosmetic Surgery, Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Stephen Schleicher
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
    • Nashville, Tennessee, United States, 37203
      • Dermatology Research Associates
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Austin, Texas, United States, 78759
      • Derm Research, Inc
    • College Station, Texas, United States, 77845
      • J&S Studies
    • Houston, Texas, United States, 77058
      • Center For Clinical Studies
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates P.A. The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78229
      • Stephen Miller MD
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD2475/101 40 mg; Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.	Drug: CD2475/101 40 mg; Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.; Drug: Placebo; Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
ACTIVE_COMPARATOR: Doxycycline 100 mg; Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.	Drug: Placebo; Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.; Drug: Doxycycline 100 mg; Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
PLACEBO_COMPARATOR: Placebo; Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.	Drug: Placebo; Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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	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.	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.	From Baseline up to Week 16

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2011
• Primary Completion (ACTUAL): January 3, 2012
• Study Completion (ACTUAL): January 3, 2012

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (ESTIMATE): March 22, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: acne vulgaris; inflammatory lesions
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: RD.06.SPR.18195