NCT04245319

Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation

Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B (Nb-UVB) on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.

Detailed description

• Twenty patients with generalized vitiligo will be included in this study. All patients will be subjected to: * Clinical evaluation: * An informed written consent. * History taking include age, previous treatment, disease activity * Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA) * Photography (before starting the treatment and every 2 weeks till the end of the study) Laboratory evaluation: * 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment. * The patients will be randomly assigned to two groups: Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily. * Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery. * Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur. * .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.

Conditions

• Hyperlipidemias
• Xerosis
• Depression
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Acitretin	The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
OTHER	Narrow band ultraviolet B	Patients receive nbUVB session 3 times per week

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-11-30
• Completion: 2021-12-01
• First posted: 2020-01-28
• Last updated: 2021-07-22

Locations

1 site across 1 country: Egypt