Improved Phototherapy in Patients With Vitiligo

NCT05836441 | Unknown

• 1 other identifier: NJmedical
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• percentage reduction in vitiligo area

  mean percentage reduction in vitiligo area from baseline to week 12

  week12 after intervention

Secondary Outcomes (2)

• percentage reduction of leukotrichia in vitiligo region

  week12 after intervention

• NB-UVB dose

  week12 after intervention

Other Outcomes (1)

• number of participants with treatment-related events such as desquamation and dryness, erythema, and blister formation.

  week12 after intervention

Study Arms (2)

White spot irradiation group

ACTIVE COMPARATOR

Exposure to white patches

Radiation: Exposure to white patches

White spot edge irradiation group

EXPERIMENTAL

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

Interventions

Exposure to white patches RADIATION

Exposure to white patches

Also known as: Tacrolimus

White spot 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

White spot edge irradiation group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first Affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Lu Yan

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

lu Yan, PhD

CONTACT

13913967126; luyan6289@163.com

Lu Yan, PhD

CONTACT

Overall Study Officials

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: January 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)