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Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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