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

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

Study Overview

• Status: Withdrawn
• Conditions: Erythema
• Intervention / Treatment: Drug: CD07805/47 Gel 0.5%; Drug: CD07805/47 Gel Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Primary Completion (ANTICIPATED): September 1, 2015

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (ESTIMATE): June 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: RD.03.SPR.40191