Rosacea Radiofrequency Microneedling

University of Miami

Status: Enrolling

Conditions: Rosacea, Erythematotelangiectatic; Rosacea, Papulopustular

Treatments: Device: KTP Laser Therapy; Device: Radiofrequency microneedling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06801717

20240859

Details and patient eligibility

About

There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic and or papulopustular rosacea, (2) to determine the potential for combination treatment of radiofrequency microneedling with the 532 nm KTP laser, and (3) identify potential novel therapeutic strategies for the treatment of rosacea.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female adult (>18yo) subjects in general good health
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

1. Patients currently utilizing oxymetazoline or brimonidine.
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling

Experimental group

Description:

Participants will be in this group for up to 36 weeks

Treatment:

Device: Radiofrequency microneedling

Device: KTP Laser Therapy