Status:

WITHDRAWN

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

Lead Sponsor:

Galderma R&D

Conditions:

Erythema

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01882712

Last Update

November 6 2014

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