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Recruiting NCT06801717

Rosacea Radiofrequency Microneedling

No phase Interventional Rosacea, Papulopustular Rosacea, Erythematotelangiectatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KTP Laser Therapy, Radiofrequency microneedling.
Who it may be relevant to
Registry conditions: Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA) [Time frame: Baseline, up to 16 weeks after the last treatment]
Secondary outcome measures (4)
  • Change in Patient reported impact on quality of life (QOL) measured by DLQI [Time frame: Baseline, up to 16 weeks after the last treatment]
  • Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA) [Time frame: Baseline, up to 16 weeks after the last treatment]
  • Change in Global Aesthetic Improvement scale (GAIS) [Time frame: Baseline, up to 16 weeks after the last treatment]
  • Proportion of blinded photo assessment [Time frame: Baseline, up to 16 weeks after the last treatment]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami Dermatology Miami Beach Clinic — Miami Beach

Identifiers

NCT: NCT06801717 · 20240859

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗