Back to resultsBrimonidine in Rosacea
Primary Purpose
Rosacea
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
treatment
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
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.
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
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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