Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo

NCT05037981 | Completed

• 1 other identifier: vit105
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• Duration needed to arrest of vitiligo activity

  Time needed for vitiligo patients to stop developing new lesions of vitiligo

  6 months

• Duration of maintaining vitiligo stability

  Time before any new vitiligo lesions reappear

  5 years

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with active localized vitiligo

You may qualify if:

• Patients ≥ 6 years old of both genders
• Early onset vitiligo (˂6m duration)
• Body surface area (BSA) affected ≤2%

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samia Esmat, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Rania Mogawer, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dalia Bassiony, MD

  Cairo University

  STUDY DIRECTOR

• Suzan Shalaby, MD

  Cairo University

  STUDY CHAIR

• Rehab Hegazy, MD

  Cairo University

  STUDY CHAIR

• Nanis Ragab, MD

  Cairo University

  STUDY CHAIR

• Sarah Ibrahim

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 8, 2021
• Study Start: October 10, 2015
• Primary Completion: August 10, 2021
• Study Completion: August 20, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share