Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

Phase 4

Active, not recruiting

• Conditions: Non-segmental Vitiligo
• Interventions: Radiation: NB-UVB; Drug: Latanoprost

• Registration Number: NCT04811326
• Lead Sponsor: Shaimaa Fawzy Abdel-rady Abdel-latif

Brief Summary

The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.

Detailed Description

the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-02-13
• Study Completion: 2024-03-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with non-segmental vitiligo of any age and gender.

Exclusion Criteria

• History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
• Pregnancy and lactation.
• Infections
• Patients with other autoimmune diseases.
• Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
NB-UVB radiation	NB-UVB	will expose to 2 sessions/week of NB-UVB radiation, for 3 months.
latanoprost + NB-UVB	NB-UVB	(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.
Latanoprost	Latanoprost	latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions).
latanoprost + NB-UVB	Latanoprost	(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.

Primary Outcome Measures

Name	Time	Method
serum TWEAK in vitiligo	3months	measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)

Secondary Outcome Measures

Name	Time	Method
treatment of vitiligo	3 months	clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance.

Trial Locations

Locations (1)

faculty of medicine, Aswan University; 🇪🇬 Aswan, Aswan Governorate, Egypt