An interventional study of KTP Laser Therapy and Radiofrequency microneedling in Rosacea, Papulopustular and Rosacea, Erythematotelangiectatic, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 20 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be in this group for up to 36 weeks
Device: KTP Laser Therapy · Device: Radiofrequency microneedling
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.
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 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
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jul 2027, 32 months after the start.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
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