Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo
1 other identifier
interventional
100
1 country
1
Brief Summary
The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedNovember 30, 2017
November 1, 2017
1.2 years
November 12, 2017
November 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Vitiligo Area Scoring Index (VASI)
* The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area. * The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. * At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present. * VASI= ∑ \[HAND UNITS\] × \[RESIDUAL DEPIGMENTATION\].
basline to 9 months
Secondary Outcomes (1)
Vitiligo Disease Activity (VIDA) Score
baseline to 9 months
Study Arms (2)
Tacrolimus group
ACTIVE COMPARATORTacrolimus 0.03% ointment twice daily for 6 months
Hydrocortisone group
ACTIVE COMPARATORhydrocortisone acetate 1% ointment twice daily for 6 months
Interventions
topical tacrolimus 0.03% twice daily for 6 months
hydrocortisone acetate 1% ointment twice daily for 6 months
Eligibility Criteria
You may qualify if:
- all patients with clinical diagnosis of vitiligo
You may not qualify if:
- children =or \<2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University
Sohag, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ramadan Saleh, MD
Sohag Faculty of Medicine, Sohag University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dermatology Resident in Farshot General Hospital, Qena, Egypt
Study Record Dates
First Submitted
November 12, 2017
First Posted
November 30, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
November 30, 2017
Record last verified: 2017-11