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Brimonidine in Rosacea

Primary Purpose

Rosacea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with current erythematotelangiectatic rosacea

Exclusion Criteria:

- Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder.

4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Pulsed dye laser

    Doxycycline

    Brimonidine gel 0.33%

    Arm Description

    Laser

    Drug

    Topical drug

    Outcomes

    Primary Outcome Measures

    Clinical erythema assessment scale
    clinical scale

    Secondary Outcome Measures

    Thickness of capillaries by dermoscope
    Assessment

    Full Information

    First Posted
    May 20, 2022
    Last Updated
    June 1, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05401422
    Brief Title
    Brimonidine in Rosacea
    Official Title
    Efficacy and Safety of Combining Doxycycline With Pulsed Dye Laser Versus Topical Brimonidine 0.33% in the Treatment of Erythematotelangiectatic Rosacea: a Comparative Clinical and Dermoscopic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.
    Detailed Description
    In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rosacea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulsed dye laser
    Arm Type
    Active Comparator
    Arm Description
    Laser
    Arm Title
    Doxycycline
    Arm Type
    Active Comparator
    Arm Description
    Drug
    Arm Title
    Brimonidine gel 0.33%
    Arm Type
    Active Comparator
    Arm Description
    Topical drug
    Intervention Type
    Other
    Intervention Name(s)
    treatment
    Intervention Description
    types
    Primary Outcome Measure Information:
    Title
    Clinical erythema assessment scale
    Description
    clinical scale
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Thickness of capillaries by dermoscope
    Description
    Assessment
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with current erythematotelangiectatic rosacea Exclusion Criteria: - Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder. 4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.

    12. IPD Sharing Statement

    Learn more about this trial

    Brimonidine in Rosacea

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