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Trial record 13 of 10941 for:    Placebo AND once

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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ClinicalTrials.gov Identifier: NCT01320033
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE March 21, 2011
First Posted Date  ICMJE March 22, 2011
Last Update Posted Date March 8, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
Inflammatory lesion counts [ Time Frame: baseline to week 16 ]
Change from Baseline to Week 16 (LOCF, ITT) in inflammatory lesion counts
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01320033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
Safety assessments [ Time Frame: baseline, weeks 2, 4, 8, 12, 16/ET ]
Adverse events, active assessment for symptomes of Pseudotumor cerebri, Physical exam, vital signs, laboratory evaluations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: CD2475/101 40 mg Tablets
    CD2475/101 40 mg Tablets once a day for 16 weeks
  • Drug: Doxycycline 100 mg Capsules
    Doxycycline 100 mg Capsules once a day for 16 weeks
  • Drug: Placebo Tablet, and Placebo Capsule
    Matching Placebo Tablet, Matching Placebo Capsule once a day for 16 weeks
Study Arms  ICMJE
  • Experimental: CD2475/101 40 mg Tablets
    CD2475/101 40 mg Tablets
    Intervention: Drug: CD2475/101 40 mg Tablets
  • Active Comparator: Doxycycline 100 mg Capsules
    Doxycycline 100 mg Capsules
    Intervention: Drug: Doxycycline 100 mg Capsules
  • Placebo Comparator: Placebo Tablet, and Placebo Capsule
    Matching Placebo Tablet, Matching Placebo Capsule
    Intervention: Drug: Placebo Tablet, and Placebo Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
662
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2011)
660
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ALT and/or 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01320033
Other Study ID Numbers  ICMJE RD.06.SPR.18195
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Graeber, MD Galderma
PRS Account Galderma
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP