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

NCT ID: NCT00668655

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea

Metronidazole Gel

Intervention Type DRUG

Topical, Once daily for 2 weeks

Interventions

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Metronidazole Gel

Topical, Once daily for 2 weeks

Intervention Type DRUG

Other Intervention Names

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MetroGel® 1%

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Dermatology Consulting Services

High Point, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21699130 (View on PubMed)

Other Identifiers

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US10086

Identifier Type: -

Identifier Source: org_study_id

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