A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

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

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-04-30

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

Detailed Description

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Conditions

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Rosacea

Keywords

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rosacea acne rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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doxycycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy patients with rosacea
* Males and females ≥18 years of age
* 10 to 40 papules and pustules and ≤2 nodules
* Score of 2 to 4 on the IGA
* Presence of telangiectasia
* Moderate to severe erythema

Exclusion Criteria

* Use of topical acne treatments or topical or systemic antibiotics
* Use of systemic retinoids within 90 days of baseline
* Use of an investigational drug within 90 days of baseline
* Pregnant or nursing women
* Women of childbearing potential not using an adequate form of contraception
* Change in method of contraception within 4 months of baseline
* Known hypersensitivity to tetracyclines
* Surgeries that bypass or exclude the duodenum or achlorhydria

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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COL-101-ROSE-301+302

Identifier Type: -

Identifier Source: org_study_id