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

NCT01882712 | Withdrawn Phase 3

• 1 other identifier: RD.03.SPR.40191
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Erythema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)

  Day 1

Study Arms (2)

CD07805/47 Gel 0.5%

EXPERIMENTAL

active arm

Drug: CD07805/47 Gel 0.5%

CD07805/47 Gel Placebo

PLACEBO COMPARATOR

Comparator arm

Drug: CD07805/47 Gel Placebo

Interventions

CD07805/47 Gel 0.5% DRUG

CD07805/47 Gel 0.5%

CD07805/47 Gel Placebo DRUG

CD07805/47 Gel Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 20, 2013
• Primary Completion: September 1, 2015
• Last Updated: November 6, 2014

Record last verified: 2014-11