Vitiligo Clinical Trial
Official title:
Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 1, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Sohag University | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Vitiligo Disease Activity (VIDA) Score | ): is a six-point scale for evaluating vitiligo activity. In this score grading is based on disease activity and time period. Grading is as follows: + 4: (activity lasting 6 weeks or less); score +3: (activity lasting 6 weeks to 3 months); score 2: (activity lasting 3-6 months); score1: (activity lasting 6-12 months); score 0: (stable for 1 year or more); score -1: (stable with spontaneous repigmentation for 1 year or more). A low Vitiligo disease activity score indicate less vitiligo activity. |
baseline to 9 months |
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