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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus group | Active Comparator | Tacrolimus 0.03% ointment twice daily for 6 months |
|
| Hydrocortisone group | Active Comparator | hydrocortisone acetate 1% ointment twice daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus 0.03% Ointment | Drug | topical tacrolimus 0.03% twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitiligo Area Scoring Index (VASI) |
| basline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitiligo Disease Activity (VIDA) Score | ): is a six-point scale for evaluating vitiligo activity.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aml Ahmed, MBBCH | Contact | 01093801703 | hanodymody12@gmail.com | |
| Ramadan Saleh, MD | Contact | 01005423054 | salehr2010@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ramadan Saleh, MD | Sohag Faculty of Medicine, Sohag University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Recruiting | Sohag | Egypt |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009824 | Ointments |
| C021650 | hydrocortisone acetate |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
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| Hydrocortisone Acetate 1% Ointment | Drug | hydrocortisone acetate 1% ointment twice daily for 6 months |
|
|
| baseline to 9 months |
| D004364 |
| Pharmaceutical Preparations |