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Vitiligo is a common acquired depigmentation skin and mucosal disease in dermatology, with or without white hair. Vitiligo with white hair is difficult to treat. Phototherapy and topical therapy are the first line treatment methods for vitiligo. The peripheral leukoplakia irradiation of phototherapy covers the central area of the leukoplakia and performs phototherapy on the edge of the leukoplakia and surrounding normal skin. This study aims to compare the efficacy and safety of peripheral leukoplakia ultraviolet family phototherapy and leukoplakia family combination in the treatment of vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White spot irradiation group | Active Comparator | Exposure to white patches |
|
| White spot edge irradiation group | Experimental | Exposure to edge of white patches and normal skin around white patches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to white patches | Radiation | Exposure to white patches |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage reduction in vitiligo area | mean percentage reduction in vitiligo area from baseline to week 12 | week12 after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| percentage reduction of leukotrichia in vitiligo region | average percentage reduction of leukotrichia in vitiligo region from baseline to week 12 | week12 after intervention |
| NB-UVB dose | Using the following Equation 1 : φ=E*T (E refers to irradiation intensity [mW/cm2] ; φ refers to irradiation dose [mJ/cm2]; T refers to irradiation time [sec]) to calculate the effective NB-UVB dose for patients at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with treatment-related events such as desquamation and dryness, erythema, and blister formation. | safety assessment involved monitoring adverse events such as desquamation and dryness, erythema, and blister formation. | week12 after intervention |
Inclusion Criteria:
â‘ Age: 5 years old and above
Gender: unlimited
Types of vitiligo: sporadic vitiligo, facial and neck vitiligo, mixed vitiligo, undetermined vitiligo
Exclusion Criteria:
â‘ Segmental vitiligo, generalized vitiligo, mucosal vitiligo, and acromegaly vitiligo;
Degree of vitiligo activity: progression, rapid progression
Kobner phenomenon or white spots located at the site of skin trauma, or other subjects requiring emergency intervention;
Subjects who are sensitive to or have contraindications to ultraviolet radiation (suffering from photosensitive diseases such as xeroderma pigmentosum, porphyria, Bloom syndrome, systemic lupus erythematosus, dysplastic nevus syndrome, dermatomyositis, etc.);
Subjects with a history of malignant tumors (including skin squamous cell carcinoma, melanoma or other skin and systemic malignant tumors);
Subjects with severe systemic diseases;
Subjects who are allergic to tacrolimus ointment or excipients in the ointment; â‘§ Subjects who have received oral or systemic medication (such as corticosteroids, cyclosporine, methotrexate, tacrolimus, etc.) aimed at controlling/improving vitiligo symptoms within 4 weeks prior to baseline, or who require systemic use of corticosteroids or immunosuppressants for other reasons;
⑨ Subjects who have received any optical therapy (including sunbathing) for vitiligo within 4 weeks prior to baseline;
â‘© Subjects who have received topical treatment aimed at controlling/improving vitiligo symptoms (such as glucocorticoids, calcineurin inhibitors, vitamin D3 derivatives, etc.) within 2 weeks prior to baseline.
⑪ Pregnant and lactating female subjects;
â‘« Subjects who are judged by researchers to be unable to implement treatment plans correctly;
⑬ Child subjects who cannot cooperate with phototherapy protective measures;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lu Yan, PhD | Contact | 13913967126 | luyan6289@163.com | |
| Lu Yan, PhD | Contact | Overall Study Officials |
| Name | Affiliation | Role |
|---|---|---|
| Lu Yan | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated hospital with Nanjing medical university | Recruiting | Nanjing | Jiangsu | 210009 | China |
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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 |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Exposure to edge of white patches and normal skin around white patches | Radiation | Exposure to edge of white patches and normal skin around white patches |
|
| week12 after intervention |