Recruiting

Radiofrequency Microneedling

Sponsor:

University of Miami

Code:

NCT06801717

Conditions

Rosacea, Papulopustular

Rosacea, Erythematotelangiectatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KTP Laser Therapy

Radiofrequency microneedling

Study Details

Brief summary:

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.

Conditions

Rosacea, Papulopustular

Rosacea, Erythematotelangiectatic

Study ID

NCT06801717

Start date

Nov 1, 2024

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Participants will be in this group for up to 36 weeks

Interventions

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.

Primary outcome measure

  • Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA) [ Time Frame: Baseline, up to 16 weeks after the last treatment ]

Central Contacts and Locations

Central contacts

Maria Muniz Muniz

305-689-2646mmuniz@med.miami.edu

Locations

University of Miami Dermatology Miami Beach Clinic

Recruiting

Miami Beach, Florida, United States, 33128

Contacts

Ariel Eber, MD

a.eber5@umiami.edu

Principal Investigator:

Ariel Eber, MD

More Information

Sponsor

University of Miami

Last update posted

Jul 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.