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

Galderma

Status and phase: Withdrawn; Phase 3

Conditions: Erythema

Treatments: Drug: CD07805/47 Gel Placebo; Drug: CD07805/47 Gel 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882712

RD.03.SPR.40191

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

CD07805/47 Gel 0.5%

Experimental group

Description:

active arm

Treatment:

Drug: CD07805/47 Gel 0.5%

CD07805/47 Gel Placebo

Placebo Comparator group

Description:

Comparator arm

Treatment:

Drug: CD07805/47 Gel Placebo