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Completed

NCT Number: NCT00668655

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

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

Completed

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole gel

Drug

Topical, Once daily for 2 weeks

Other names: MetroGel® 1%

Secondary outcomes

  1. Assessment of Cosmetic Appearance by Investigator

    Time frame: Baseline and Week 2

  2. Assessment of Cosmetic Appearance by Subject

    Time frame: Baseline and Week 2

  3. Erythema Severity

    Time frame: Baseline and Week 2

  4. Investigator Global Severity Score

    Time frame: Baseline and Week 2

  5. Tolerability Assessments and incidence of adverse events

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2008
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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