Rosacea Radiofrequency Microneedling

NCT ID: NCT06801717

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rosacea, Papulopustular Rosacea, Erythematotelangiectatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Participants will be in this group for up to 36 weeks

Group Type EXPERIMENTAL

KTP Laser Therapy

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LUTRONIC Corporation

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ariel Eva Eber

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel Eber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Dermatology Miami Beach Clinic

Miami Beach, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maria Muniz Muniz

Role: CONTACT

305-689-2646

Facility Contacts

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Ariel Eber, MD

Role: primary

Other Identifiers

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20240859

Identifier Type: -

Identifier Source: org_study_id

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