Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Not Applicable

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

• Registration Number: NCT05488860
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-30
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional injection	Triamcinolone acetonide(scar)/5-ALA(others)	Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases.
Piezoelectric drived microneedling	5-ALA (a photosensitizer for photodynamic therapy).	Intralesional injection of drug by piezoelectric drived microneedles.
Piezoelectric drived microneedling	Piezoelectric drived microneedling	Intralesional injection of drug by piezoelectric drived microneedles.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, China