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Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Primary Purpose

Skin Diseases, Hypertrophic Scar, Keloid

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Triamcinolone acetonide(scar)/5-ALA(others)
Piezoelectric drived microneedling
5-ALA (a photosensitizer for photodynamic therapy).
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases focused on measuring Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Xiangya HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional injection

Piezoelectric drived microneedling

Arm 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.

Intralesional injection of drug by piezoelectric drived microneedles.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pain score during treatment
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
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.

Full Information

First Posted
August 1, 2022
Last Updated
August 4, 2022
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05488860
Brief Title
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases
Official Title
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Hypertrophic Scar, Keloid, Plantar Wart, Warts, Skin Tumor
Keywords
Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional injection
Arm Type
Active Comparator
Arm 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.
Arm Title
Piezoelectric drived microneedling
Arm Type
Experimental
Arm Description
Intralesional injection of drug by piezoelectric drived microneedles.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide(scar)/5-ALA(others)
Other Intervention Name(s)
Intralesional drug delivery
Intervention Description
For scar, the drug is triamcinolone acetonide.
Intervention Type
Procedure
Intervention Name(s)
Piezoelectric drived microneedling
Intervention Description
Piezoelectric drived microneedling
Intervention Type
Drug
Intervention Name(s)
5-ALA (a photosensitizer for photodynamic therapy).
Intervention Description
For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).
Primary Outcome Measure Information:
Title
Short-term response
Description
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
Time Frame
1 week after treatment
Title
Long-term response
Description
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
Time Frame
1 month after treatment
Secondary Outcome Measure Information:
Title
Pain score during treatment
Description
Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain
Time Frame
Immediately
Title
POSAS(The Patient and Observer Scar Assessment Scale) score
Description
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.
Time Frame
1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Xiangya Hospital
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zixi Jiang
Phone
13278883845
Email
jiangzixi@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

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