Clinical trial NCT06801717: Rosacea Radiofrequency Microneedling
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rosacea, Papulopustular
Rosacea, Erythematotelangiectatic
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: LUTRONIC Corporation
First posted: 2025-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA)
timeFrame: Baseline, up to 16 weeks after the last treatment
Secondary outcomes:
measure: Change in Patient reported impact on quality of life (QOL) measured by DLQI
timeFrame: Baseline, up to 16 weeks after the last treatment
measure: Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)
timeFrame: Baseline, up to 16 weeks after the last treatment
measure: Change in Global Aesthetic Improvement scale (GAIS)
timeFrame: Baseline, up to 16 weeks after the last treatment
measure: Proportion of blinded photo assessment
timeFrame: Baseline, up to 16 weeks after the last treatment
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: University of Miami Dermatology Miami Beach Clinic
state: Florida
Study officials:
affiliation: University of Miami
name: Ariel Eber, MD
role: PRINCIPAL_INVESTIGATOR
References: