Rosacea Radiofrequency Microneedling

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
University of Miami
Study ID
NCT06801717
Status
Recruiting

Conditions

  • Rosacea, Erythematotelangiectatic
  • Rosacea, Papulopustular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KTP Laser Therapy — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling
    Participants will be in this group for up to 36 weeks

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Dermatology Miami Beach ClinicMiami BeachFlorida33128
Ariel Eber, MD
Ariel Eber, MD (PRINCIPAL_INVESTIGATOR)
Alyx Aigen, MD (SUB_INVESTIGATOR)
Gabriela E Beraja, DO (SUB_INVESTIGATOR)

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