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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
University of Miami Dermatology Miami Beach Clinic
Miami Beach, Florida, United States
RECRUITINGChange 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.
Time frame: Baseline, up to 16 weeks after the last treatment
Change in Patient reported impact on quality of life (QOL) measured by DLQI
Dermatology Quality of Life Index (DLQI) is a validated 10-item questionnaire assessing the impact of dermatological conditions on a patient's QOL, with scores ranging from 0 (no impact) to 30 (extremely large impact). Higher scores indicate higher impact on QOL.
Time frame: Baseline, up to 16 weeks after the last treatment
Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)
The PSA scale measures the patient's subjective satisfaction with skin's appearance on a scale of 0 (clear of unwanted redness) to 4 (completely unacceptable redness). Higher scores indicate less satisfaction.
Time frame: Baseline, up to 16 weeks after the last treatment
Change in Global Aesthetic Improvement scale (GAIS)
The GAIS scores range from 1 (very much improved) to 5 (the appearance is worse than the original condition). Higher scores indicate less satisfaction.
Time frame: Baseline, up to 16 weeks after the last treatment
Proportion of blinded photo assessment
Proportion of identification of before and after photos by three blinded rosacea experts will be reported. Expert identification greater than or equal to 80% or greater will be reported.
Time frame: Baseline, up to 16 weeks after the last treatment
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