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Improved Phototherapy in Patients With Vitiligo

Primary Purpose

Vitiligo

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exposure to white patches
Exposure to edge of white patches and normal skin around white patches
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ① Age: 5 years old and above Gender: unlimited Types of vitiligo: sporadic vitiligo, facial and neck vitiligo, mixed vitiligo, undetermined vitiligo Vitiligo course: unlimited; ⑤ Vitiligo activity level: stable period; ⑥ At least one white spot meets the following four conditions simultaneously: Location: limited to the neck, trunk, and limbs (excluding hairless areas of hands and feet); There are no contraindications for the use of NB UVB phototherapy and topical tacrolimus; Area: 1cm2 < white spot area < 1% body surface area; The vellus hair in the white spot area is all white; ⑦ It is agreed to discontinue all forms of treatment that may change the study outcome during the study period, including western medicine, traditional Chinese medicine, traditional Chinese patent medicines and simple preparations, biological agents, etc., such as Dihydroketiazide, 8-M0P, osteotonic, angelica dahurica, etc; Willing and able to follow the visit and treatment plan. Exclusion Criteria: ① 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; ⑧ 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; ⑩ 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; ⑫ Subjects who are judged by researchers to be unable to implement treatment plans correctly; ⑬ Child subjects who cannot cooperate with phototherapy protective measures;

Sites / Locations

  • The first Affiliated hospital with Nanjing medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

White spot irradiation group

White spot edge irradiation group

Arm Description

Exposure to white patches

Exposure to edge of white patches and normal skin around white patches

Outcomes

Primary Outcome Measures

percentage reduction in vitiligo area
mean percentage reduction in vitiligo area from baseline to week 12

Secondary Outcome Measures

percentage reduction of leukotrichia in vitiligo region
average percentage reduction of leukotrichia in vitiligo region from baseline to week 12
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

Full Information

First Posted
April 17, 2023
Last Updated
April 28, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05836441
Brief Title
Improved Phototherapy in Patients With Vitiligo
Official Title
A Multicenter, Randomized, Open, Parallel Controlled Clinical Study Evaluating the Efficacy and Safety of Improved Phototherapy in Patients With Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
White spot irradiation group
Arm Type
Active Comparator
Arm Description
Exposure to white patches
Arm Title
White spot edge irradiation group
Arm Type
Experimental
Arm Description
Exposure to edge of white patches and normal skin around white patches
Intervention Type
Radiation
Intervention Name(s)
Exposure to white patches
Other Intervention Name(s)
Tacrolimus
Intervention Description
Exposure to white patches
Intervention Type
Radiation
Intervention Name(s)
Exposure to edge of white patches and normal skin around white patches
Intervention Description
Exposure to edge of white patches and normal skin around white patches
Primary Outcome Measure Information:
Title
percentage reduction in vitiligo area
Description
mean percentage reduction in vitiligo area from baseline to week 12
Time Frame
week12 after intervention
Secondary Outcome Measure Information:
Title
percentage reduction of leukotrichia in vitiligo region
Description
average percentage reduction of leukotrichia in vitiligo region from baseline to week 12
Time Frame
week12 after intervention
Title
NB-UVB dose
Description
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
Time Frame
week12 after intervention
Other Pre-specified Outcome Measures:
Title
number of participants with treatment-related events such as desquamation and dryness, erythema, and blister formation.
Description
safety assessment involved monitoring adverse events such as desquamation and dryness, erythema, and blister formation.
Time Frame
week12 after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ① Age: 5 years old and above Gender: unlimited Types of vitiligo: sporadic vitiligo, facial and neck vitiligo, mixed vitiligo, undetermined vitiligo Vitiligo course: unlimited; ⑤ Vitiligo activity level: stable period; ⑥ At least one white spot meets the following four conditions simultaneously: Location: limited to the neck, trunk, and limbs (excluding hairless areas of hands and feet); There are no contraindications for the use of NB UVB phototherapy and topical tacrolimus; Area: 1cm2 < white spot area < 1% body surface area; The vellus hair in the white spot area is all white; ⑦ It is agreed to discontinue all forms of treatment that may change the study outcome during the study period, including western medicine, traditional Chinese medicine, traditional Chinese patent medicines and simple preparations, biological agents, etc., such as Dihydroketiazide, 8-M0P, osteotonic, angelica dahurica, etc; Willing and able to follow the visit and treatment plan. Exclusion Criteria: ① 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; ⑧ 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; ⑩ 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; ⑫ Subjects who are judged by researchers to be unable to implement treatment plans correctly; ⑬ Child subjects who cannot cooperate with phototherapy protective measures;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lu Yan, PhD
Phone
13913967126
Email
luyan6289@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Yan, PhD
Phone
Overall Study Officials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Yan
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The first Affiliated hospital with Nanjing medical university
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Na
Phone
18253707792
Email
leina0829@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Improved Phototherapy in Patients With Vitiligo

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