Hypertrophic Scar, Keloid, Plantar Wart, Skin Diseases, Skin Tumor, Warts
Conditions
Keywords
Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived
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.
Interventions
DRUGTriamcinolone acetonide(scar)/5-ALA(others)
For scar, the drug is triamcinolone acetonide.
PROCEDUREPiezoelectric drived microneedling
Piezoelectric drived microneedling
DRUG5-ALA (a photosensitizer for photodynamic therapy).
For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed