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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