Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo

Vitiligo Clinical Trial

Official title:

Evaluation of Early Systemic Stabilization Therapy on Recent Onset Localized Non-segmental Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037981
• Other study ID #: vit105
• Status: Completed
• Start date: October 10, 2015
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 20, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients = 6 years old of both genders

• Early onset vitiligo (?6m duration)

• Body surface area (BSA) affected =2%

Exclusion Criteria:

• Patients who received any previous treatment for vitiligo

• Pregnant and lactating females

• Patients with other cutaneous or systemic autoimmune diseases

• Patients with contraindication to systemic corticosteroids

Related Conditions & MeSH terms

• Vitiligo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration needed to arrest of vitiligo activity	Time needed for vitiligo patients to stop developing new lesions of vitiligo	6 months
Primary	Duration of maintaining vitiligo stability	Time before any new vitiligo lesions reappear	5 years