Rosacea Radiofrequency Microneedling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
KTP Laser Therapy
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency MicroneedlingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change 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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
CynosureLutronic
Collaborator
Source ClinicalTrials.gov