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Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema

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ClinicalTrials.gov Identifier: NCT01882712
Recruitment Status : Withdrawn
First Posted : June 20, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema

Condition or disease Intervention/treatment Phase
Erythema Drug: CD07805/47 Gel 0.5% Drug: CD07805/47 Gel Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Estimated Primary Completion Date : September 2015

Arm Intervention/treatment
Experimental: CD07805/47 Gel 0.5%
active arm
Drug: CD07805/47 Gel 0.5%
Placebo Comparator: CD07805/47 Gel Placebo
Comparator arm
Drug: CD07805/47 Gel Placebo



Primary Outcome Measures :
  1. Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) [ Time Frame: Day 29 ]
    2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29


Secondary Outcome Measures :
  1. Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) [ Time Frame: Day 1 ]
    1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, who is at least 18 years of age or older at screening visit.
  • Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
  • A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
  • A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

  • More than 2 facial inflammatory lesions (papules, pustules, and nodules).
  • Presence of areas of significant scaling or crusting on the face.
  • Presence of psoriatic lesions on the face.
  • Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01882712    
Other Study ID Numbers: RD.03.SPR.40191
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations