Skin Diseases Clinical Trial
Official title:
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
Verified date | July 2022 |
Source | Xiangya Hospital of Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital | Changsha |
Lead Sponsor | Collaborator |
---|---|
Xiangya Hospital of Central South University |
China,
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 |
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