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

Primary Purpose

Erythema

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CD07805/47 Gel 0.5%
CD07805/47 Gel Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CD07805/47 Gel 0.5%

    CD07805/47 Gel Placebo

    Arm Description

    active arm

    Comparator arm

    Outcomes

    Primary Outcome Measures

    Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
    2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29

    Secondary Outcome Measures

    Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
    1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1

    Full Information

    First Posted
    June 14, 2013
    Last Updated
    November 5, 2014
    Sponsor
    Galderma R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01882712
    Brief Title
    Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Galderma R&D

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erythema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CD07805/47 Gel 0.5%
    Arm Type
    Experimental
    Arm Description
    active arm
    Arm Title
    CD07805/47 Gel Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Comparator arm
    Intervention Type
    Drug
    Intervention Name(s)
    CD07805/47 Gel 0.5%
    Intervention Type
    Drug
    Intervention Name(s)
    CD07805/47 Gel Placebo
    Primary Outcome Measure Information:
    Title
    Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
    Description
    2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29
    Time Frame
    Day 29
    Secondary Outcome Measure Information:
    Title
    Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
    Description
    1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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