Rosacea Radiofrequency Microneedling

NCT06801717 | Recruiting FDA Device

• 1 other identifier: 20240859
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Patient reported impact on quality of life (QOL) measured by DLQI

  Baseline, up to 16 weeks after the last treatment

• Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)

  Baseline, up to 16 weeks after the last treatment

• Change in Global Aesthetic Improvement scale (GAIS)

  Baseline, up to 16 weeks after the last treatment

• Proportion of blinded photo assessment

  Baseline, up to 16 weeks after the last treatment

Study Arms (1)

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

EXPERIMENTAL

Participants will be in this group for up to 36 weeks

Device: KTP Laser Therapy; Device: Radiofrequency microneedling

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult (\>18yo) subjects in general good health
• Clinical and/or histologic diagnosis of erythematotelangiectatic or papulopustular rosacea.
• Subject is able to understand and sign informed consent
• Subject is able to complete the study and comply with study procedures

You may not qualify if:

• Patients currently utilizing oxymetazoline or brimonidine.
• Presence of dermatoses that might interfere with diagnosis as determined by a study investigator
• Presence of extreme light sensitivity, or conditions pre-disposing to light sensitivity such as but not limited to xeroderma pigmentosum
• Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
• History of poor wound healing or blood-clotting abnormality
• History of keloid formation or hypertrophic scarring
• Hypersensitivity or contraindication to local anesthetics as determined by the principal investigator or other medical professional.
• Prisoners

Sponsors & Collaborators

• CynosureLutronic: collaborator
• University of Miami: lead

Study Sites (1)

University of Miami Dermatology Miami Beach Clinic

Miami Beach, Florida, 33128, United States

RECRUITING

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ariel Eber, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Muniz Muniz

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)