Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05488860

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases Hypertrophic Scar Keloid Plantar Wart Warts Skin Tumor	Drug: Triamcinolone acetonide(scar)/5-ALA(others) Procedure: Piezoelectric drived microneedling Drug: 5-ALA (a photosensitizer for photodynamic therapy).	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Triamcinolone acetonide(scar)/5-ALA(others) For scar, the drug is triamcinolone acetonide. Other Names: Intralesional drug delivery
Experimental: Piezoelectric drived microneedling Intralesional injection of drug by piezoelectric drived microneedles.	Procedure: Piezoelectric drived microneedling Piezoelectric drived microneedling Drug: 5-ALA (a photosensitizer for photodynamic therapy). For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).

Arm

Intervention/Treatment

Active Comparator: 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.

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

For scar, the drug is triamcinolone acetonide.

Other Names:

Intralesional drug delivery

Experimental: Piezoelectric drived microneedling

Intralesional injection of drug by piezoelectric drived microneedles.

Procedure: Piezoelectric drived microneedling

Piezoelectric drived microneedling

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

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

Outcome Measures

Primary Outcome Measures

Short-term response [1 week after treatment]
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
Long-term response [1 month after treatment]
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.

Secondary Outcome Measures

Pain score during treatment [Immediately]
Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain
POSAS(The Patient and Observer Scar Assessment Scale) score [1 month after treatment]
A widely used scar scale for evaluating the severity of scar by both patients and dermatologists. Score ranged from 11 to 110. The higher score means severer condition of scar.