Improved Phototherapy in Patients With Vitiligo

Not Applicable

Recruiting

• Conditions: Vitiligo
• Interventions: Radiation: Exposure to edge of white patches and normal skin around white patches; Radiation: Exposure to white patches

• Registration Number: NCT05836441
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
White spot irradiation group	Exposure to white patches	Exposure to white patches

Primary Outcome Measures

Name	Time	Method
percentage reduction in vitiligo area	week12 after intervention	mean percentage reduction in vitiligo area from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
percentage reduction of leukotrichia in vitiligo region	week12 after intervention	average percentage reduction of leukotrichia in vitiligo region from baseline to week 12
NB-UVB dose	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

Trial Locations

Locations (1)

The first Affiliated hospital with Nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China