Clinical Study on the Treatment of Melasma with Fractional Radiofrequency Microneedles Combined with Polyglutamic Acid

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600127304

Enrollment

Unknown

Registered

2026-06-29

Start date

2026-08-16

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Melasma

Interventions

Control group:Fractional Microneedle Radiofrequency Treatment for Melasma

Experimental group:The Treatment of Melasma with Fractional Radiofrequency Microneedles Combined with Polyglutamic Acid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with concurrent facial inflammatory or pigmented skin diseases, such as rosacea, hormone-dependent dermatitis, vitiligo, psoriasis, and seborrheic dermatitis 2. Women who are pregnant, breastfeeding, or planning to conceive during the study period 3. Individuals with coagulation disorders 4. Individuals with impaired wound healing or a keloid-prone constitution 5. Patients with severe systemic diseases or psychiatric disorders 6. Individuals with active facial infections or cutaneous malignancies 7. Individuals allergic to polyglutamic acid, radiofrequency treatment-related consumables, or ingredients in cold compress repair masks 8. Individuals with poor compliance, unable to complete treatment and follow-up visits as required, or refusing to cooperate with efficacy assessments

Exclusion criteria

Exclusion criteria: 1.Other facial inflammatory or pigmentary skin diseases; 2.Pregnant, lactating or planning pregnancy; 3.Coagulation disorders; 4.Poor wound healing or keloid tendency; 5.Severe systemic or psychiatric diseases; 6.Active facial infection or skin malignancy; 7. Allergy to polyglutamic acid, RF consumables or mask ingredients; 8.Poor compliance to treatment and follow-up;

Design outcomes

Primary

Measure	Time frame
Melasma Area and Severity Index (MASI);Physician's Global Assessment (PGA);Patient Satisfaction Assessment;	—

Secondary

Measure	Time frame
Erythema Index by Skin Function Analyzer;Melanin Index by Skin Function Analyzer;Trans Epidermal Water Loss (TEWL) by Skin Function Analyzer;Surface Pigmentation Assessment by VISIA Imaging;UV Pigmentation Assessment by VISIA Imaging;Dermal Brown Spot Assessment by VISIA Imaging;Deep Vascular Assessment by VISIA Imaging;	—

Countries

China

Contacts

Public ContactYang Li

Henan Provincial People's Hospita,medical

19423427@qq.com+86 15515912211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026