Efficacy and Safety of Potenza RF Microneedling in Rosacea: A Randomized, Evaluator Blinded, Split Face, Single Center Prospective Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011272

Enrollment

Registered

2025-12-08

Start date

2025-12-31

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Each participant’s left/right facial side is randomized (1:1) to Active RadioFrequency(RF) vs Sham. Two treatment sessions are performed at Week 0 and Week 4. Week 8 is the primary en

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 19–70 years; clinical diagnosis of rosacea (erythematotelangiectatic ± papulopustular) 2. Stable disease for =3 months (no severe flare) 3. Bilateral, symmetric involvement including malar regions (suitable for split face design) 4. Ability to comply with study procedures and provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Energy based facial procedures (laser/RF/strong peels) to target areas within 6 months 2. Oral isotretinoin within 3 months; systemic corticosteroids/immunosuppressants within 1 month 3. Pregnancy or lactation; pacemaker/implantable electronic device; active facial infection; keloid tendency 4. Photosensitizing drugs; severe confounding dermatoses (e.g., severe acne) affecting assessments 5. Any condition judged by investigators to preclude safe participation or adherence

Design outcomes

Primary

Measure	Time frame
Change from baseline in Clinician Erythema Assessment (CEA, 0–4) on treated vs control sides	—

Secondary

Measure	Time frame
Objective erythema indices: standardized cross polarized/RBX imaging metrics or colorimetry/erythema index (zone wise means);Erythema distribution/intensity:(forehead, each malar region, nose, chin) five zone area proportion (%) and heat map grade;Porphyrin metrics: image based porphyrin score/area ;Skin barrier function: Transepidermal Water Loss(TEWL) and stratum corneum hydration (SCH).;Texture/pores: roughness (Ra/Rq) and pore count/mean area ;sensitive skin index (SS 10; 0–100);patient satisfaction (5 point scale).;Safety: immediate pain NRS (0–10); AE rates/severity/duration and relatedness (none/possible/probable/definite);Explore associations between treatment parameters (needle depth, energy level, number of passes) and outcomes;Conduct blinded visual similarity/overall improvement Visual Analogue Scale(VAS) (0–100) on standardized photo pairs.	—

Measure

Time frame

Objective erythema indices: standardized cross polarized/RBX imaging metrics or colorimetry/erythema index (zone wise means);Erythema distribution/intensity:(forehead, each malar region, nose, chin) five zone area proportion (%) and heat map grade;Porphyrin metrics: image based porphyrin score/area ;Skin barrier function: Transepidermal Water Loss(TEWL) and stratum corneum hydration (SCH).;Texture/pores: roughness (Ra/Rq) and pore count/mean area ;sensitive skin index (SS 10; 0–100);patient satisfaction (5 point scale).;Safety: immediate pain NRS (0–10); AE rates/severity/duration and relatedness (none/possible/probable/definite);Explore associations between treatment parameters (needle depth, energy level, number of passes) and outcomes;Conduct blinded visual similarity/overall improvement Visual Analogue Scale(VAS) (0–100) on standardized photo pairs.

—

Countries

Korea, Republic of

Contacts

Public ContactHyeOne KIM

Hallym University Medical Center-Kangnam

hyeonekim@gmail.com+82-2-829-5221

Outcome results