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Trial Title: Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

NCT ID: NCT05488860

Condition: Skin Diseases
Hypertrophic Scar
Keloid
Plantar Wart
Warts
Skin Tumor

Conditions: Official terms:
Warts
Skin Diseases
Cicatrix, Hypertrophic
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Aminolevulinic Acid
Photosensitizing Agents
Triamcinolone diacetate

Conditions: Keywords:
Microneedling
Ultrasound
Refractory skin diseases
Piezoelectric drived

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

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)

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

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.

Criteria for 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

Locations:

Facility:
Name: Xiangya Hospital

Address:
City: Changsha
Zip: 410008
Country: China

Status: Recruiting

Contact:
Last name: Zixi Jiang

Phone: 13278883845
Email: jiangzixi@csu.edu.cn

Start date: July 30, 2022

Completion date: July 31, 2024

Lead sponsor:
Agency: Xiangya Hospital of Central South University
Agency class: Other

Source: Xiangya Hospital of Central South University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05488860

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