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

Erythema Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01882712
• Other study ID #: RD.03.SPR.40191
• Status: Withdrawn
• Phase: Phase 3
• First received: June 14, 2013
• Last updated: November 5, 2014

Study information

• Verified date: November 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythema

Intervention

Drug:
• CD07805/47 Gel 0.5%

• CD07805/47 Gel Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No