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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Detailed Description

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Conditions

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Erythema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CD07805/47 Gel 0.5%

active arm

Group Type EXPERIMENTAL

CD07805/47 Gel 0.5%

Intervention Type DRUG

CD07805/47 Gel Placebo

Comparator arm

Group Type PLACEBO_COMPARATOR

CD07805/47 Gel Placebo

Intervention Type DRUG

Interventions

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CD07805/47 Gel 0.5%

Intervention Type DRUG

CD07805/47 Gel Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No