Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Warts; Plantar Wart; Keloid; Hypertrophic Scar; Skin Tumor
• Intervention / Treatment: Drug: Triamcinolone acetonide(scar)/5-ALA(others); Procedure: Piezoelectric drived microneedling; Drug: 5-ALA (a photosensitizer for photodynamic therapy).

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changsha, China, 410008
    • Recruiting
    • Xiangya Hospital
    • Contact: Zixi Jiang; Phone Number: 13278883845; Email: jiangzixi@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 30, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): July 31, 2024

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (ACTUAL): August 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Microneedling; Refractory skin diseases; Piezoelectric drived
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Fibrosis; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Cicatrix; Skin Diseases; Warts; Cicatrix, Hypertrophic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Triamcinolone; Aminolevulinic Acid; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Photosensitizing Agents
• Other Study ID Numbers: XiangyaDerm0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No