Improved Phototherapy in Patients With Vitiligo

NCT ID: NCT05836441

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-30

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

White spot irradiation group

Exposure to white patches

Group Type: ACTIVE_COMPARATOR

Exposure to white patches

Intervention Type: RADIATION

Exposure to white patches

White spot edge irradiation group

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

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

Interventions

Exposure to white patches

Exposure to white patches

Intervention Type: 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

Intervention Type: RADIATION

Other Intervention Names

Tacrolimus

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;

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lu Yan

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

The first Affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

lu Yan, PhD

Role: CONTACT

luyan6289@163.com

13913967126

Lu Yan, PhD

Role: CONTACT

Overall Study Officials

Facility Contacts

Lei Na

Role: primary

leina0829@163.com

18253707792

Other Identifiers

NJmedical

Identifier Type: -

Identifier Source: org_study_id