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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Radiation: Exposure to white patches; Radiation: Exposure to edge of white patches and normal skin around white patches

• Study Type: Interventional
• Enrollment (Anticipated): 110
• 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

• China
  • 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: No

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: White spot irradiation group; Exposure to white patches	Radiation: Exposure to white patches; Exposure to white patches; Other Names: Tacrolimus
Experimental: White spot edge irradiation group; 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; 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	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	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	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.	safety assessment involved monitoring adverse events such as desquamation and dryness, erythema, and blister formation.	week12 after intervention

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Lu Yan, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: NJmedical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No