An Evaluation of the Cosmetic Appearance of Metronidazole... | NCT00668655

Studies
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

NCT00668655

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Rosacea

Interventions

Metronidazole Gel

Countries

United States

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

Sep 2012

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

Feb 2008

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Apr 25, 2008

First Submission Date that Met QC Criteria

Apr 28, 2008

First Posted Date

Apr 29, 2008Estimated

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

Jul 28, 2022

Last Update Posted Date

Jul 29, 2022Actual

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 determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Detailed Description

Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea	Drug: Metronidazole Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole Gel	Drug	Topical, Once daily for 2 weeks	1	MetroGel® 1%

Outcomes Module

Primary Outcomes

Not provided

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Cosmetic Appearance by Investigator		Baseline and Week 2
Assessment of Cosmetic Appearance by Subject		Baseline and Week 2
Erythema Severity		Baseline and Week 2
Investigator Global Severity Score		Baseline and Week 2
Tolerability Assessments and incidence of adverse events		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with moderate Rosacea (Global Severity Score of 3),
Subjects willing to stop their current rosacea medication for at least 2 weeks
Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study)
Subjects must be willing to use their routine facial foundation and not change products while on study

Exclusion Criteria:

Subjects who do not routinely wear facial foundation
Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide)
Subjects who are unwilling to stop their current rosacea medications for 2 weeks

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Community Sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald W Gottschalk, MD	Galderma R&D	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Consulting Services		High Point	North Carolina	27262	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21699130	Derived	Draelos ZD, Colon LE, Preston N, Johnson LA, Gottschalk RW. The appearance of facial foundation cosmetics applied after metronidazole gel 1%. Cutis. 2011 May;87(5):251-9.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases