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
This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.
Microneedling is a minimally invasive technique developed for skin rejuvenation. In the treatment for vitiligo, the procedure causes micro-inflammations on the epidermis and enhances melanocytes and keratinocytes migration. This process leads to the stimulation and repigmentation of vitiligo areas. Several topical therapies such as Tacrolimus and 5-Fluorouracilused in conjunction with microneedling have yielded favorable repigmentation results. This study aims to evaluate the repigmentation rates of microneedled vitiligo patches without any topical medications other than sunscreen.
There will be a total of 8 -12 treatments over the course of 244 days, with subjects receiving a treatment every 2 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling with Skinpen Precision System | Experimental | Skinpen precision system will be used in accordance with the instructions in the IFU on the treatment area. A numbing cream will be applied at least 20-30 minutes before the Skinpen Precision system treatment is done. The affected areas will be treated at depths of up to 2.50mm. Treatment depth will be recorded for each treatment at every visit. Subjects will be dispensed with the Blue Lizard sunscreen and trained on proper use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skinpen Precision System | Device | Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) | PGA to be completed starting at Visit 2 and on, prior to each treatment. The primary endpoint is to achieve Grade 2, 3 or 4 on the PGA Scale comparing photographs from baseline to visits 12, 13, and 14. This is a 5 Grade Repigmentation Scale. This assessment uses a scale of G0-G4. This global assessment will be done by the investigator starting at Visit 2 and afterwards. G4 Excellent > 75% Repigmentation G3 Very Good 50%-75% Repigmentation G2 Good 25%-50% Repigmentation G1 Satisfactory <25% Repigmentation G0 Poor No Repigmentation | Through Study Completion, over the course of 244 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale (VNS) | Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale. A score of 3,4, or 5 indicates the success of the treatment. | Through Study Completion, over the course of 244 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crown Laboratories | Dallas | Texas | 75234 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
A proof of concept study to determine the safety and efficacy of Microneedling in patients with stable Vitiligo.
Not provided
Not provided
Not provided
Not provided