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CompletedNCT01320033Updated Feb 18, 2021Results posted

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 Phase 2 interventional study of CD2475/101 40 mg and Doxycycline 100 mg in Acne Vulgaris, sponsored by Galderma R&D. Completed at 31 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Galderma R&D · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
662
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • acne vulgaris
  • inflammatory lesions
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 662 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
662 participants (actual)

Study arms

  • 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 · Drug: Placebo

  • Active comparator
    Doxycycline 100 mg

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

    Drug: Doxycycline 100 mg · Drug: Placebo

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugCD2475/101 40 mg

    Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.

  • DrugDoxycycline 100 mg

    Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks

  • DrugPlacebo

    Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

06

What researchers measure

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.

    Time frame: From Baseline up to Week 16 (LOCF)

Secondary outcomes

  1. 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).

    Time frame: Week 16 (LOCF)

  2. 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.

    Time frame: From Baseline up to Week 16 (LOCF)

  3. 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.

    Time frame: From Baseline up to Week 16 (LOCF)

  4. 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

    Time frame: From Baseline up to Week 16 (LOCF)

  5. 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.

    Time frame: Baseline, Week 12, and Week 16

  6. 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.

    Time frame: From Baseline up to Week 16

07

Results

Posted Feb 10, 2020

Participant flow

This study was conducted in United States between 29 March 2011 (first participant first visit) to 3 January 2012 (last participant last visit).

Participant flow — Overall Study
MilestoneCD2475/101 40 mgDoxycycline 100 mgPlacebo
Started216224222
Completed158160169
Not completed586453
Withdrew: Lack of efficacy001
Withdrew: Adverse event978
Withdrew: Withdrawal by subject222323
Withdrew: Protocol violation353
Withdrew: Lost to follow-up222617
Withdrew: Other231

Outcome measures

PrimaryChange 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.

Time frame:
From Baseline up to Week 16 (LOCF)
Reported as:
Mean · lesion count
Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
lesion countCD2475/101 40 mgDoxycycline 100 mgPlacebo
Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])-16.1 ± 11.39-12.9 ± 14.60-12.6 ± 16.44
Statistical analysis
  • CD2475/101 40 mg vs Placebo · ANCOVA · p = 0.006 · Mean difference (final values): -3.6 · 95% CI -6.1 to -1.1
  • CD2475/101 40 mg vs Doxycycline 100 mg · ANCOVA · p = 0.024 · Mean difference (final values): -2.9 · 95% CI -5.4 to -0.4
  • Doxycycline 100 mg vs Placebo · ANCOVA · p = 0.595 · Mean difference (final values): -0.7 · 95% CI -3.2 to 1.8
SecondaryInvestigator 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).

Time frame:
Week 16 (LOCF)
Reported as:
Number · Percentage of participants
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
Percentage of participantsCD2475/101 40 mgDoxycycline 100 mgPlacebo
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])14.413.87.7
SecondaryPercent 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.

Time frame:
From Baseline up to Week 16 (LOCF)
Reported as:
Mean · percent change
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
percent changeCD2475/101 40 mgDoxycycline 100 mgPlacebo
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])-48.6 ± 31.72-40.3 ± 40.90-37.1 ± 44.45
SecondaryPercent 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.

Time frame:
From Baseline up to Week 16 (LOCF)
Reported as:
Mean · percent change
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
percent changeCD2475/101 40 mgDoxycycline 100 mgPlacebo
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])-38.3 ± 32.24-27.8 ± 43.94-27.8 ± 38.05
SecondaryChange 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

Time frame:
From Baseline up to Week 16 (LOCF)
Reported as:
Mean · lesion count
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
lesion countCD2475/101 40 mgDoxycycline 100 mgPlacebo
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])-10.0 ± 21.49-5.2 ± 21.60-5.8 ± 18.19
SecondaryGlobal 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.

Time frame:
Baseline, Week 12, and Week 16
Reported as:
Mean · Units on a scale
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Units on a scaleCD2475/101 40 mgDoxycycline 100 mgPlacebo
Baseline : Lesion of Truncal Acne on Back1.6 ± 1.101.5 ± 1.091.5 ± 1.07
Baseline : Lesion of Truncal Acne on Chest1.2 ± 1.041.2 ± 1.001.1 ± 0.98
Week 12 : Lesions of Truncal Acne on Back1.2 ± 1.061.1 ± 1.051.2 ± 1.04
Week 12 : Lesion of Truncal Acne on Chest0.9 ± 0.940.9 ± 0.990.9 ± 0.95
Week 16 : Lesions of Truncal Acne on Back1.1 ± 1.061.0 ± 1.061.2 ± 1.03
Week 16 : Lesion of Truncal Acne on Chest0.9 ± 1.010.8 ± 0.930.9 ± 0.95
SecondaryNumber 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.

Time frame:
From Baseline up to Week 16
Reported as:
Count of participants · Participants
Number of Participants With at Least One Adverse Event (AE)
ParticipantsCD2475/101 40 mgDoxycycline 100 mgPlacebo
Number of Participants With at Least One Adverse Event (AE)638389

Adverse events

Collected over From Baseline up to Week 16. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CD2475/101 40 mg0/216 (0%)1/216 (0.5%)29/216 (13.4%)
Doxycycline 100 mg0/223 (0%)4/223 (1.8%)51/223 (22.9%)
Placebo0/222 (0%)2/222 (0.9%)29/222 (13.1%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventCD2475/101 40 mgDoxycycline 100 mgPlacebo
Affective disorderPsychiatric disorders1/2160/2230/222
Suicide attemptPsychiatric disorders0/2160/2231/222
DepressionPsychiatric disorders0/2161/2231/222
CoagulopathyBlood and lymphatic system disorders0/2160/2231/222
Multiple drug overdose intentionalInjury, poisoning and procedural complications0/2160/2231/222
Multiple sclerosis relapseNervous system disorders0/2160/2231/222
Hepatic encephalopathyNervous system disorders0/2160/2231/222
Forearm fractureInjury, poisoning and procedural complications0/2161/2230/222
FallInjury, poisoning and procedural complications0/2161/2230/222
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2161/2230/222
Most frequent other events
Most frequent other events
EventCD2475/101 40 mgDoxycycline 100 mgPlacebo
HeadacheNervous system disorders14/21615/2236/222
VomitingGastrointestinal disorders1/21615/2235/222
NasopharyngitisInfections and infestations7/2167/22314/222
NauseaGastrointestinal disorders7/21614/2234/222

Baseline characteristics

Intent-to-treat (ITT) Population consisted of all participants who were randomized and to whom study drug was dispensed.

Age, Categorical
Age, Categorical(Participants)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
<=18 years123132133388
Between 18 and 65 years939289274
>=65 years0000
Age, Continuous
Age, Continuous(Years)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
Mean19.6 ± 7.7019.6 ± 7.5418.7 ± 6.3419.3 ± 7.21
Sex: Female, Male
Sex: Female, Male(Participants)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
Female115121115351
Male101103107311
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
Hispanic or Latino353037102
Not Hispanic or Latino181194185560
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
American Indian or Alaska Native0000
Asian47718
Native Hawaiian or Other Pacific Islander0000
Black or African American474940136
White159163170492
More than one race0000
Unknown or Not Reported65516
Region of Enrollment
Region of Enrollment(participants)CD2475/101 40 mgDoxycycline 100 mgPlaceboTotal
United States216224222662
08

Study locations

31 sites
  • 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
    Saint 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01320033
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Mar 22, 2011
Start date
Mar 29, 2011
Primary completion
Jan 3, 2012
Completion
Jan 3, 2012
Results posted
Feb 10, 2020
Last update
Feb 18, 2021

Study contacts

Michael Graeber, MD
study director · Galderma R&D

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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