Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

NCT ID: NCT00495313

Last Updated: 2008-12-16

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

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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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%

Detailed Description

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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%

Conditions

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Rosacea

Keywords

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: doxycycline

Vibramycin plus metronidazole

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

COL-101, QD plus metronidazole

Cohort 2

Oracea® delayed release plus metronidazole

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

40 mg with metronidazole QD

Interventions

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doxycycline

COL-101, QD plus metronidazole

Intervention Type DRUG

doxycycline

40 mg with metronidazole QD

Intervention Type DRUG

Other Intervention Names

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Vibramycin, 100 mg, QD plus metornidazole Oracea® 40 mg plus metronidazole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CollaGenex Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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CollaGenex Pharmaceuticals

Principal Investigators

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Christopher V Powala, JD

Role: STUDY_CHAIR

CollaGenex Pharmaceuticals

Locations

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Joel Schlessinger

Omaha, Nebraska, United States

Site Status

James Del Rosso

Las Vegas, Nevada, United States

Site Status

Angela Moore

Arlington, Texas, United States

Site Status

William Abramovits

Dallas, Texas, United States

Site Status

Douglas Forsha

West Jordan, Utah, United States

Site Status

Bernard Goffe

Seattle, Washington, United States

Site Status

William Werschler

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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COL101-ROSE-401

Identifier Type: -

Identifier Source: org_study_id