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Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

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ClinicalTrials.gov Identifier: NCT03358082
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Aml Abd Elaziz Ahmed, Sohag University

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.

Condition or disease Intervention/treatment Phase
Vitiligo Tacrolimus Drug: Tacrolimus 0.03% Ointment Drug: Hydrocortisone Acetate 1% Ointment Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 1, 2019


Arm Intervention/treatment
Active Comparator: Tacrolimus group
Tacrolimus 0.03% ointment twice daily for 6 months
Drug: Tacrolimus 0.03% Ointment
topical tacrolimus 0.03% twice daily for 6 months
Other Name: Tarolimus ointment

Active Comparator: Hydrocortisone group
hydrocortisone acetate 1% ointment twice daily for 6 months
Drug: Hydrocortisone Acetate 1% Ointment
hydrocortisone acetate 1% ointment twice daily for 6 months
Other Name: Texacort ointment




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Vitiligo Disease Activity (VIDA) Score [ Time Frame: baseline to 9 months ]

    ): 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.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358082


Contacts
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Contact: Aml Ahmed, MBBCH 01093801703 hanodymody12@gmail.com
Contact: Ramadan Saleh, MD 01005423054 salehr2010@yahoo.com

Locations
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Egypt
Sohag University Recruiting
Sohag, Egypt
Contact: Aml Ahmed, MBBCH    01093801703    hanodymody12@gmail.com   
Contact: Ramadan Saleh, MD    01005423054    salehr2010@yahoo.com   
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Ramadan Saleh, MD Sohag Faculty of Medicine, Sohag University

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Responsible Party: Aml Abd Elaziz Ahmed, Dermatology Resident in Farshot General Hospital, Qena, Egypt, Sohag University
ClinicalTrials.gov Identifier: NCT03358082     History of Changes
Other Study ID Numbers: Tacvit01
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents