Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo

NCT03199664 | Unknown Phase 4 DMC

• 1 other identifier: tcrnbvtlg
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months .All types of vitiligo will be included except universal vitiligo.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Vitiligo Area Scoring Index (VASI)

  The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites \[Hand Units\] ´ \[Residual depigmentation\].

  baseline to 9 months

Secondary Outcomes (1)

• Vitiligo Disease Activity (VIDA) score

  baseline to 9 months

Study Arms (2)

Group A (NB-UVB)

ACTIVE COMPARATOR

Intervention: patients will be treated with Narrow band ultra violet rays alone for 6 months

Radiation: NB-UVB

Group B ( combined NB-UVB & Tacrolimus)

ACTIVE COMPARATOR

Intervention: patients will be treated with NB-UVB \& Tacrolimus 0.03 % ointment for 6 months

Combination Product: NB-UVB & Tacrolimus 0.03%

Interventions

NB-UVB RADIATION

NB-UVB given twice weekly for 6 months

Group A (NB-UVB)

NB-UVB & Tacrolimus 0.03% COMBINATION_PRODUCT

NB-UVB given twice weekly for 6 months and tacrolimus 0.03 % ointment given for twice daily for the first month of treatment and once daily for the rest 5 months of treatment

Group B ( combined NB-UVB & Tacrolimus)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with clinical diagnosis of vitiligo.

You may not qualify if:

• Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South valley university

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramdan Saleh, MD

  Sohag Faculty of Medicine, Sohag university

  STUDY DIRECTOR

Central Study Contacts

Noha Samir, MBBCh

CONTACT

01001248106; noha_samir89@yahoo.com

Ramdan Saleh, MD

CONTACT

01005423054; salehr2010@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology resident at South Valley University Students' Hospital

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 27, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

EG (1)