Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skin Diseases Hypertrophic Scar Keloid Plantar Wart Warts Skin Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison is designed in each participant. For each individual, two similar hypertrophic scar/keloid or a single hypertrophic scar/keloid is randomly assigned into traditional injection group or piezoelectric divied microneedling group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional injection

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

For scar, the drug is triamcinolone acetonide.

Piezoelectric drived microneedling

Intralesional injection of drug by piezoelectric drived microneedles.

Group Type EXPERIMENTAL

Piezoelectric drived microneedling

Intervention Type PROCEDURE

Piezoelectric drived microneedling

5-ALA (a photosensitizer for photodynamic therapy).

Intervention Type DRUG

For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).

Interventions

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

For scar, the drug is triamcinolone acetonide.

Intervention Type DRUG

Piezoelectric drived microneedling

Intervention Type PROCEDURE

5-ALA (a photosensitizer for photodynamic therapy).

For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).

Intervention Type DRUG

Other Intervention Names

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Intralesional drug delivery

Eligibility Criteria

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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