Phase 3 Efficacy and Safety Study of CD07805/47 Topical G... | NCT01882712

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

NCT01882712

Sponsor

Galderma R&D

Status

Withdrawn

Last Update Posted

Nov 6, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Erythema

Interventions

CD07805/47 Gel 0.5%
CD07805/47 Gel Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Sep 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 14, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2014

Last Update Posted Date

Nov 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CD07805/47 Gel 0.5%	Drug		CD07805/47 Gel 0.5%
CD07805/47 Gel Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004890	Erythema

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided