Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Study Overview
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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.

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.

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

Conditions
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Skin Diseases, Hypertrophic Scar, Keloid, Plantar Wart, Warts, Skin Tumor

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


Participation Criteria
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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 Exclusion Criteria: Poor general condition Bleeding tendency Allergy to drug

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional injection<br>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)<br>* For scar, the drug is triamcinolone acetonide.<br>* Other names: Intralesional drug delivery;|
| Experimental: Piezoelectric drived microneedling<br>Intralesional injection of drug by piezoelectric drived microneedles. | Procedure: Piezoelectric drived microneedling<br>* Piezoelectric drived microneedling<br>Drug: 5-ALA (a photosensitizer for photodynamic therapy).<br>* For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term response | This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully. | 1 week after treatment | 
| Long-term response | This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully. | 1 month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score during treatment | Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain | Immediately | 
| POSAS(The Patient and Observer Scar Assessment Scale) score | 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. | 1 month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived