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The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.
The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.
Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.
The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Area 1: Excimer laser, bimatoprost, and microneedling | Experimental |
| |
| Area 2: Excimer laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of skin repigmentation after 12 weeks | A blinded outcome accessor will compare photographs of patients before and after treatment. | Post treatment (at week 12) |
| Number of patients with perceived improvement after 12 weeks. | Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | To access vitiligo patient specifically though a QOL reliable and valid scale. | Baseline and post treatment approximately 12 weeks |
| Change in quality of life | To access quality of life via a validated general Dermatology Life Quality Index Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29407 | United States |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D054018 | Lasers, Excimer |
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| Excimer laser | Device | Participants will be receiving excimer laser 2x a week for 12 weeks |
|
| Microneedling with a dermaroller | Device | Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks |
|
| Baseline and post treatment approximately 12 weeks |
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
| D012046 | Rehabilitation |