RecruitingNot ApplicableNCT06801717

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


Sponsor

University of Miami

Enrollment

20 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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

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Interventions

DEVICEKTP 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.

DEVICERadiofrequency 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.


Locations(1)

University of Miami Dermatology Miami Beach Clinic

Miami Beach, Florida, United States

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NCT06801717