A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

NCT ID: NCT00417937

Last Updated: 2023-06-09

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-06-30

Brief Summary

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To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Detailed Description

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To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Azelaic acid 15 % gel once daily

Group Type ACTIVE_COMPARATOR

azelaic acid 15% gel

Intervention Type DRUG

15% gel, topically applied once daily for six weeks

2

Azelaic acid 15 gel twice daily

Group Type ACTIVE_COMPARATOR

azelaic acid 15% gel

Intervention Type DRUG

15% gel, topically applied twice daily for six weeks

Interventions

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azelaic acid 15% gel

15% gel, topically applied once daily for six weeks

Intervention Type DRUG

azelaic acid 15% gel

15% gel, topically applied twice daily for six weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria

* Mild or severe rosacea
* Rosacea with marked ocular manifestations
* Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
* Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
* History of hypersensitivity to propylene glycol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Intendis GmbH

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1401460

Identifier Type: OTHER

Identifier Source: secondary_id

14428

Identifier Type: -

Identifier Source: org_study_id

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