Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional injection | Active Comparator | Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases. |
|
| Piezoelectric drived microneedling | Experimental | Intralesional injection of drug by piezoelectric drived microneedles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone acetonide(scar)/5-ALA(others) | Drug | For scar, the drug is triamcinolone acetonide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score during treatment | Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain | Immediately |
| POSAS(The Patient and Observer Scar Assessment Scale) score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital | Recruiting | Changsha | 410008 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Piezoelectric drived microneedling | Procedure | Piezoelectric drived microneedling |
|
| 5-ALA (a photosensitizer for photodynamic therapy). | Drug | For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy). |
|
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 |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017439 | Cicatrix, Hypertrophic |
| D007627 | Keloid |
| D014860 | Warts |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
Not provided
Not provided