Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Central South University

Status: Enrolling

Conditions: Keloid; Skin Tumor; Skin Diseases; Plantar Wart; Hypertrophic Scar; Warts

Treatments: Procedure: Piezoelectric drived microneedling; Drug: 5-ALA (a photosensitizer for photodynamic therapy).; Drug: Triamcinolone acetonide(scar)/5-ALA(others)

Study type: Interventional

Funder types: Other

Identifiers

NCT05488860

XiangyaDerm0002

Details and patient eligibility

About

Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.

Full description

Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.

Enrollment: 20 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age over 16 years
• Diagnosed by 2 or more professional dermatologists
• Willing to underwent a new treatment modality
• Follow up is easy to conduct

Exclusion criteria

• Poor general condition
• Bleeding tendency
• Allergy to drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Traditional injection

Active Comparator group

Description:

Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases.

Treatment:

Drug: Triamcinolone acetonide(scar)/5-ALA(others)

Piezoelectric drived microneedling

Experimental group

Description:

Intralesional injection of drug by piezoelectric drived microneedles.

Treatment:

Drug: 5-ALA (a photosensitizer for photodynamic therapy).

Procedure: Piezoelectric drived microneedling