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A study on evaluating the safety and effectiveness of fractional microneedle radiofrequency in the treatment of Melasma

A study on evaluating the safety and effectiveness of fractional microneedle radiofrequency in the treatment of Melasma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071506
Enrollment
Unknown
Registered
2023-05-17
Start date
2023-05-17
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

melasma

Interventions

Experimental group:fractional microneedle radiofrequency

Sponsors

Southern Medical University, Dermatology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Stable stage of melamsa (not in inflammatory erythema period); 2) Aged 18-50 years; 3) Agree to follow the experimental treatment plan and visit plan, voluntarily enroll, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Any uncontrollable serious or potentially affecting clinical system disease history/surgical history for treatment and effectiveness evaluation, such as circulatory system, nervous system, hematological system, immune system, mental system diseases, etc; 2) Receiving other facial rejuvenation treatments during the treatment period; 3) Exposure to sunlight without protective measures during treatment; 4) Have a history of malignant tumors; 5) The patient has uncontrollable hypertension (blood pressure above 140 mmHg/90 mmHg), or a history of hypotension (blood pressure below 90 mmHg/60 mmHg); 6) Recent history (within 3 months prior to screening) of surgery or planning to undergo major surgery during the trial period; 7) Individuals who have participated or are currently participating in clinical trials of other intervention drugs or medical devices within the first 3 months of screening; 8) Three months prior to screening, other medications such as phototherapy, oral tranexamic acid, glutathione, oral contraceptives, isotretinoic acid, minocycline, etc. that affect the condition of melasma or have photosensitive properties were received; 9) History of drug abuse, drug use, or alcohol dependence prior to screening; 10)The researcher believes that the subject has other situations that may affect compliance or be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
modified melasma area and severity index;

Secondary

MeasureTime frame
Subject self-evaluation;VISIA image analysis system;

Countries

China

Contacts

Public ContactLiu zhenfeng

Dermatology Hospital, Southern Medical University

liuzhenfengpuma@163.com+86 180 1178 8797

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026