Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Sohag University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Vitiligo Area Scoring Index (VASI)
Study Overview
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.
Detailed Description
Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.
Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology & Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.
Patients and methods:
Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.
Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients with clinical diagnosis of vitiligo
Exclusion Criteria
- •children =or <2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
Arms & Interventions
Tacrolimus group
Tacrolimus 0.03% ointment twice daily for 6 months
Intervention: Tacrolimus 0.03% Ointment (Drug)
Hydrocortisone group
hydrocortisone acetate 1% ointment twice daily for 6 months
Intervention: Hydrocortisone Acetate 1% Ointment (Drug)
Outcomes
Primary Outcomes
Vitiligo Area Scoring Index (VASI)
Time Frame: basline to 9 months
* 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= ∑ \[HAND UNITS\] × \[RESIDUAL DEPIGMENTATION\].
Secondary Outcomes
- Vitiligo Disease Activity (VIDA) Score(baseline to 9 months)
Investigators
Aml Abd Elaziz Ahmed
Dermatology Resident in Farshot General Hospital, Qena, Egypt
Sohag University