Rosacea Radiofrequency Microneedling

Split-Face Comparison of 532nm Potassium Titanyl Phosphate (KTP) Laser Treatment Versus Radiofrequency Microneedling in Combination With 532 KTP Laser for Erythematotelangiectatic or Papulopustular Rosacea

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.

Study Overview

• Status: Recruiting
• Conditions: Rosacea, Papulopustular; Rosacea, Erythematotelangiectatic
• Intervention / Treatment: Device: KTP Laser Therapy; Device: Radiofrequency microneedling

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Muniz Muniz; Phone Number: 305-689-2646; Email: mmuniz@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami Beach, Florida, United States, 33128
      • Recruiting
      • University of Miami Dermatology Miami Beach Clinic
      • Contact: Ariel Eber, MD; Email: a.eber5@umiami.edu
      • Principal Investigator: Ariel Eber, MD
      • Sub-Investigator: Alyx Aigen, MD
      • Sub-Investigator: Gabriela E Beraja, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA)	Score range from 0 (clear skin) to 4 (severe erythema). Lower scores indicate less rosacea severity as assessed by the CEA scale.	Baseline, up to 16 weeks after the last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient reported impact on quality of life (QOL) measured by DLQI	Dermatology Quality of Life Index (DLQI) is a validated 10-item questionnaire assessing the impact of dermatological conditions on a patient's QOL, with scores ranging from 0 (no impact) to 30 (extremely large impact). Higher scores indicate higher impact on QOL.	Baseline, up to 16 weeks after the last treatment
Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)	The PSA scale measures the patient's subjective satisfaction with skin's appearance on a scale of 0 (clear of unwanted redness) to 4 (completely unacceptable redness). Higher scores indicate less satisfaction.	Baseline, up to 16 weeks after the last treatment
Change in Global Aesthetic Improvement scale (GAIS)	The GAIS scores range from 1 (very much improved) to 5 (the appearance is worse than the original condition). Higher scores indicate less satisfaction.	Baseline, up to 16 weeks after the last treatment
Proportion of blinded photo assessment	Proportion of identification of before and after photos by three blinded rosacea experts will be reported. Expert identification greater than or equal to 80% or greater will be reported.	Baseline, up to 16 weeks after the last treatment

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: CynosureLutronic
• Investigators: Principal Investigator: Ariel Eber, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Rosacea
• Other Study ID Numbers: 20240859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No