Study of 0444 Gel in the Treatment of Inflammatory Lesion... | NCT01016782

Studies
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

NCT01016782

Sponsor

Fougera Pharmaceuticals Inc.

Status

Completed

Last Update Posted

Jul 4, 2014Estimated

Enrollment

867Actual

Phase

Phase 3

Conditions

Inflammatory Rosacea

Interventions

0444

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 18, 2009

First Posted Date

Nov 19, 2009Estimated

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

Jun 30, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 2, 2014

Certification/Extension First Posted Date

Jul 4, 2014Estimated

Last Update Submitted Date

Jul 2, 2014

Last Update Posted Date

Jul 4, 2014Estimated

Description Module

Brief Summary

The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.

Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

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

867Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	Test product that contains active pharmaceutical ingredient	Drug: 0444
Reference	Active Comparator	Reference product that contains active pharmaceutical ingredient	Drug: 0444
Vehicle	Placebo Comparator	Placebo that contains no active pharmaceutical ingredient	Drug: 0444

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0444	Drug	A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days	Reference Test Vehicle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in the number of papules and pustules from Baseline to End of Treatment		70 Days

Secondary Outcomes

Measure	Description	Time Frame
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear		70 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of rosacea
Good health with the exception of rosacea
Papsules and pustules minimum and maximum requirements

Exclusion Criteria:

Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
Subjects who have any systemic or dermatological disorders with the exception of rosacea

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela C Kaplan	Fougera Pharmaceuticals Inc.	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided