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NCT Number: NCT06801717

Rosacea Radiofrequency Microneedling

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.

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Key information

Conditions

Rosacea, Papulopustular Rosacea Rosacea, Erythematotelangiectatic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Dermatology Miami Beach Clinic

Miami Beach, Florida, 33128, United States

Location status: Recruiting

Location contact

Alyx Aigen, MD

SUB_INVESTIGATOR

Ariel Eber, MD

CONTACT

[email protected]

Ariel Eber, MD

PRINCIPAL_INVESTIGATOR

Gabriela E Beraja, DO

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

KTP Laser Therapy

Device

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 microneedling

Device

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.

Primary outcomes

  1. Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA)

    Time frame: 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 outcomes

  1. Change in Patient reported impact on quality of life (QOL) measured by DLQI

    Time frame: 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.

  2. Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)

    Time frame: 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.

  3. Change in Global Aesthetic Improvement scale (GAIS)

    Time frame: 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.

  4. Proportion of blinded photo assessment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Muniz Muniz

CONTACT

[email protected]

305-689-2646

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • CynosureLutronic

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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