Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
Conditions
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.
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.
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.
Sponsors
LUTRONIC Corporation
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA) | Baseline, up to 16 weeks after the last treatment | Score range from 0 (clear skin) to 4 (severe erythema). Lower scores indicate less rosacea severity as assessed by the CEA scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient reported impact on quality of life (QOL) measured by DLQI | Baseline, up to 16 weeks after the last treatment | 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. |
| Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA) | Baseline, up to 16 weeks after the last treatment | 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. |
| Change in Global Aesthetic Improvement scale (GAIS) | Baseline, up to 16 weeks after the last treatment | The GAIS scores range from 1 (very much improved) to 5 (the appearance is worse than the original condition). Higher scores indicate less satisfaction. |
| Proportion of blinded photo assessment | Baseline, up to 16 weeks after the last treatment | 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. |
Countries
United States
Contacts
Primary ContactMaria Muniz Muniz
Outcome results
None listed