Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Skin Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488860
• Other study ID #: XiangyaDerm0002
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2022
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Keloid
• Plantar Wart
• Skin Diseases
• Warts

Intervention

Drug:
• Triamcinolone acetonide(scar)/5-ALA(others)
For scar, the drug is triamcinolone acetonide.

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).

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain score during treatment	Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain	Immediately
Secondary	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