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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245319
• Other study ID #: Acitretin in vitiligo
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Noha A. Saleh, M.Sc
• Phone: +201222177210
• Email: noushy2938[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with generalized non-segmental vitiligo (25%-75%)
• Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
• Age more than 18 years.

Exclusion Criteria:

• Children ? 18 years old
• Pregnant females
• Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
• Patients receiving treatment for vitiligo within the past 2 months.
• Patients with abnormal liver profile
• Patients with abnormal lipid profile
• Patients with associated photosensitive disorders
• Patients having associated skin diseases other than vitiligo
• Cataract and aphakia
• High cumulative dose from previous sessions of narrowband ? 200-300 session

Related Conditions & MeSH terms

• Depression
• Hyperlipidemias
• Liver Diseases
• Vitiligo
• Xerosis

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index	The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)	4-5 months
Primary	Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.	The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).	4-5 months