Rosacea, PapulopustularNCT06801717
Rosacea Radiofrequency Microneedling
A study testing KTP Laser Therapy and Radiofrequency microneedling in people with Rosacea, Papulopustular and Rosacea, Erythematotelangiectatic, run by University of Miami at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
- What is being tested?
- KTP Laser Therapy and Radiofrequency microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Dermatology Miami Beach Clinic
Miami Beach, Florida, 33128
Ariel Eber, MD, a.eber5@umiami.edu
Ariel Eber, MD
About this study
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
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.
- Being tested
- KTP Laser Therapy, Radiofrequency microneedling
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTP Laser TherapyDevice
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.
Radiofrequency microneedlingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling | Experimental | Participants will be in this group for up to 36 weeks Receives: Device: KTP Laser Therapy; Device: Radiofrequency microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 16 weeks after the last treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, up to 16 weeks after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rosacea, PapulopustularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- CynosureLutronic
- Responsible party
- Principal investigator, Ariel Eva Eber, University of Miami
- Investigators
- Ariel Eber, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801717
- Sponsor's protocol ID
- 20240859
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No