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Completed

NCT Number: NCT00495313

Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joel Schlessinger, Omaha, Nebraska, United States

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About this study

Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 8-40 total lesions
  • erythema
  • telangiectasia

Exclusion criteria

  • non-pregnant, non-lactating
  • achlorhydric
  • gastric by-pass surgery
  • allergy to study medications
  • drug/alcohol abuse
  • use of proton pump inhibitors

Treatment and study plan

Doxycycline

Drug

COL-101, QD plus metronidazole

Other names: Vibramycin, 100 mg, QD plus metornidazole

Primary outcomes

  1. Change in total lesion count from Baseline at the study endpoint

    Time frame: 16 weeks

Secondary outcomes

  1. Change in Investigator's Global Assessment from Baseline at the study endpoint

    Time frame: 16 weeks

  2. Change in Clinician's Erythema Assessment score from Baseline at the study endpoint

    Time frame: 16 weeks

  3. Change in total lesion count (papules + pustules + nodules) from Baseline at each visit

    Time frame: 4 weeks, 8 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

CollaGenex Pharmaceuticals

Industry

Registry information

Official study title

Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 3, 2007
Registry last updated
Dec 16, 2008

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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