Treatment of Patients With Blepharitis and Facial Rosacea

NCT ID: NCT00560703

Last Updated: 2021-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea

Detailed Description

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Conditions

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Blepharitis Meibomianitis Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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COL-101 (doxycycline, USP) capsules

COL-101

Group Type ACTIVE_COMPARATOR

COL-101 (doxycycline, USP) capsules

Intervention Type DRUG

40mg, once per day for 84 days

Placebo

Sugar capsule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

sugar capsule

Interventions

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COL-101 (doxycycline, USP) capsules

40mg, once per day for 84 days

Intervention Type DRUG

placebo

sugar capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* blepharitis
* facial rosacea

Exclusion Criteria

* pregnant or nursing women
* allergy to tetracyclines
* recent eye surgery
* past or current use of isotretinoin
* patients who are achlorhydric
* patients who have had gastric by-pass surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Michael Graeber, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Pleasant Valley Ophthalmology

Little Rock, Arkansas, United States

Site Status

Warren Scherer, MD

Naples, Florida, United States

Site Status

Kentucky Lions Eye Center

Louisville, Kentucky, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Marguerite McDonald, MD

Lynbrook, New York, United States

Site Status

Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Anita Nevyas-Wallace, MD

Bala-Cynwyd, Pennsylvania, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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COL-101-BLEPH-201

Identifier Type: -

Identifier Source: org_study_id

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