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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04245319
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias; Xerosis; Depression; Liver Diseases	Drug: Acitretin; Other: Narrow band ultraviolet B	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 0.3 mg/kg/day daily.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 0.3 mg/kg/day daily.
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Nov 30, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: NbUVB Group A: patients will receive three NB-UVB sessions per week for 48 sessions.	Other: Narrow band ultraviolet B; Patients receive nbUVB session 3 times per week
Experimental: Combined nbUVB and Acitretin 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.	Drug: Acitretin; The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed; Other Names: Acitretin 25Mg Cap Acitretin 10Mg Cap ; Other: Narrow band ultraviolet B; Patients receive nbUVB session 3 times per week

Outcome Measures

Primary Outcome Measures

1. Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index [4-5 months]

   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)

2. Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score. [4-5 months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	11956

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shahira Ramadan, Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04245319
• Other Study ID Numbers: Acitretin in vitiligo
• First Posted: Jan 28, 2020
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Vitiligo; Hyperlipidemias; Acitretin

Study Results

No Results Posted as of Jul 22, 2021