Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

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

Sponsors

Lead Sponsor: Xiangya Hospital of Central South University

Source Xiangya Hospital of Central South University
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.

Detailed 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.

Overall Status Recruiting
Start Date 2022-07-30
Completion Date 2024-07-31
Primary Completion Date 2024-06-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Short-term response 1 week after treatment
Long-term response 1 month after treatment
Secondary Outcome
Measure Time Frame
Pain score during treatment Immediately
POSAS(The Patient and Observer Scar Assessment Scale) score 1 month after treatment
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Triamcinolone acetonide(scar)/5-ALA(others)

Description: For scar, the drug is triamcinolone acetonide.

Arm Group Label: Traditional injection

Other Name: Intralesional drug delivery

Intervention Type: Procedure

Intervention Name: Piezoelectric drived microneedling

Description: Piezoelectric drived microneedling

Arm Group Label: Piezoelectric drived microneedling

Intervention Type: Drug

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

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

Arm Group Label: Piezoelectric drived microneedling

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Xiangya Hospital Zixi Jiang 13278883845 [email protected]
Location Countries

China

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Traditional injection

Type: Active Comparator

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.

Label: Piezoelectric drived microneedling

Type: Experimental

Description: Intralesional injection of drug by piezoelectric drived microneedles.

Patient Data No
Study Design Info

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.

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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Clinical Trials on Skin Diseases

Clinical Trials on Triamcinolone acetonide(scar)/5-ALA(others)