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

Sponsor
Galderma R&D (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01882712
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CD07805/47 Gel 0.5%
  • Drug: CD07805/47 Gel Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Anticipated Primary Completion Date :
Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) [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) [Day 1]

    1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01882712
Other Study ID Numbers:
  • RD.03.SPR.40191
First Posted:
Jun 20, 2013
Last Update Posted:
Nov 6, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:
Erythema

Study Results

No Results Posted as of Nov 6, 2014