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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01320033
First received: March 21, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Drug: CD2475/101 40 mg Tablets
Drug: Doxycycline 100 mg Capsules
Drug: Placebo Tablet, and Placebo Capsule
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Inflammatory lesion counts [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    Change from Baseline to Week 16 (LOCF, ITT) in inflammatory lesion counts


Secondary Outcome Measures:
  • Safety assessments [ Time Frame: baseline, weeks 2, 4, 8, 12, 16/ET ] [ Designated as safety issue: No ]
    Adverse events, active assessment for symptomes of Pseudotumor cerebri, Physical exam, vital signs, laboratory evaluations


Enrollment: 662
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD2475/101 40 mg Tablets
CD2475/101 40 mg Tablets
 Drug: CD2475/101 40 mg Tablets
CD2475/101 40 mg Tablets once a day for 16 weeks
Active Comparator: Doxycycline 100 mg Capsules
Doxycycline 100 mg Capsules
 Drug: Doxycycline 100 mg Capsules
Doxycycline 100 mg Capsules once a day for 16 weeks
Placebo Comparator: Placebo Tablet, and Placebo Capsule
Matching Placebo Tablet, Matching Placebo Capsule
 Drug: Placebo Tablet, and Placebo Capsule
Matching Placebo Tablet, Matching Placebo Capsule once a day for 16 weeks

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320033

  Show 31 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01320033     History of Changes
Other Study ID Numbers: RD.06.SPR.18195
Study First Received: March 21, 2011
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
acne vulgaris
inflammatory lesions

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Doxycycline
Doxycycline hyclate
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013