Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03358082
Other study ID # Tacvit01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received November 12, 2017
Last updated November 29, 2017
Start date October 1, 2017
Est. completion date February 1, 2019

Study information

Verified date November 2017
Source Sohag University
Contact Aml Ahmed, MBBCH
Phone 01093801703
Email hanodymody12@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tacrolimus 0.03% Ointment
topical tacrolimus 0.03% twice daily for 6 months
Hydrocortisone Acetate 1% Ointment
hydrocortisone acetate 1% ointment twice daily for 6 months

Locations

Country Name City State
Egypt Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05298033 - Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo Phase 2
Recruiting NCT05872477 - Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas Phase 2
Terminated NCT04374435 - Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo N/A
Completed NCT04103060 - Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo Phase 2
Terminated NCT04271501 - Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions N/A
Completed NCT04530344 - Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo Phase 3
Not yet recruiting NCT05008887 - Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo Phase 4
Terminated NCT02191748 - Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo Phase 2/Phase 3
Terminated NCT01262547 - A New Micrografting Technique for Vitiligo Phase 2
Completed NCT01382589 - Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Phase 2
Active, not recruiting NCT04971200 - Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo Early Phase 1
Completed NCT04872257 - Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo N/A
Completed NCT04547998 - Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions N/A
Not yet recruiting NCT04039451 - Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
Not yet recruiting NCT03611348 - Microneedling and Latanoprost in Acrofacial Vitiligo Phase 2/Phase 3
Recruiting NCT03199664 - Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo Phase 4
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT03249064 - Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2