- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836441
Improved Phototherapy in Patients With Vitiligo
A Multicenter, Randomized, Open, Parallel Controlled Clinical Study Evaluating the Efficacy and Safety of Improved Phototherapy in Patients With Vitiligo
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: lu Yan, PhD
- Phone Number: 13913967126
- Email: luyan6289@163.com
Study Contact Backup
- Name: Lu Yan, PhD
- Phone Number: Overall Study Officials
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- The First Affiliated Hospital with Nanjing Medical University
-
Contact:
- Lei Na
- Phone Number: 18253707792
- Email: leina0829@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: White spot irradiation group
Exposure to white patches
|
Exposure to white patches
Other Names:
|
Experimental: White spot edge irradiation group
Exposure to edge of white patches and normal skin around white patches
|
Exposure to edge of white patches and normal skin around white patches
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage reduction in vitiligo area
Time Frame: week12 after intervention
|
mean percentage reduction in vitiligo area from baseline to week 12
|
week12 after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage reduction of leukotrichia in vitiligo region
Time Frame: week12 after intervention
|
average percentage reduction of leukotrichia in vitiligo region from baseline to week 12
|
week12 after intervention
|
NB-UVB dose
Time Frame: week12 after intervention
|
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
|
week12 after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of participants with treatment-related events such as desquamation and dryness, erythema, and blister formation.
Time Frame: week12 after intervention
|
safety assessment involved monitoring adverse events such as desquamation and dryness, erythema, and blister formation.
|
week12 after intervention
|
Collaborators and Investigators
Investigators
- Study Chair: Lu Yan, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJmedical
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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