Study Results
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-01
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling
Participants will be in this group for up to 36 weeks
KTP Laser Therapy
Participants will receive full face treatments with 532 nm KTP laser for 3 sessions at 8-12 weeks apart. Laser therapy will be conducted in person. Each laser treatment session will last up to 10 minutes.
Radiofrequency microneedling
Participants will receive unilateral facial treatments with radiofrequency microneedling device for 3 sessions at 8-12 weeks apart. Radiofrequency microneedling will be conducted in person. Each treatment session will last up to 1 hour.
Interventions
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KTP Laser Therapy
Participants will receive full face treatments with 532 nm KTP laser for 3 sessions at 8-12 weeks apart. Laser therapy will be conducted in person. Each laser treatment session will last up to 10 minutes.
Radiofrequency microneedling
Participants will receive unilateral facial treatments with radiofrequency microneedling device for 3 sessions at 8-12 weeks apart. Radiofrequency microneedling will be conducted in person. Each treatment session will last up to 1 hour.
Eligibility Criteria
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Inclusion Criteria
2. Clinical and/or histologic diagnosis of erythematotelangiectatic or papulopustular rosacea.
3. Subject is able to understand and sign informed consent
4. Subject is able to complete the study and comply with study procedures
Exclusion Criteria
2. Presence of dermatoses that might interfere with diagnosis as determined by a study investigator
3. Presence of extreme light sensitivity, or conditions pre-disposing to light sensitivity such as but not limited to xeroderma pigmentosum
4. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
5. History of poor wound healing or blood-clotting abnormality
6. History of keloid formation or hypertrophic scarring
7. Hypersensitivity or contraindication to local anesthetics as determined by the principal investigator or other medical professional.
8. Prisoners
18 Years
ALL
No
Sponsors
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LUTRONIC Corporation
INDUSTRY
University of Miami
OTHER
Responsible Party
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Ariel Eva Eber
Assistant Professor
Principal Investigators
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Ariel Eber, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Dermatology Miami Beach Clinic
Miami Beach, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240859
Identifier Type: -
Identifier Source: org_study_id
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