Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Phototherapy, tacrolimus, vitiligo
Eligibility Criteria
Inclusion Criteria:
- patients having 20-60 years of age
- non pregnant
- no history of photosensitivity
- no history of immunosuppression or immunosuppressive drugs
- no histry of steroids use oral or topical in last four weeks
Exclusion Criteria:
- pregnancy
- lactation
- history of photosensitivity
- photo-aggravated dermatoses
- history of any immunosuppressive disorder or use of immunosuppressive medicine
- history of using steroids either oral or injectable within the previous one month
- history of skin malignancy
Sites / Locations
- cmh Abbottabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group A topical tacrolimus 0.03% with uvb phototherapy
Group B topical placebo twice daily with uvb phototherapy thrice weekly
Arm Description
Group A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks
Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks
Outcomes
Primary Outcome Measures
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
Secondary Outcome Measures
Full Information
NCT ID
NCT05577637
First Posted
October 10, 2022
Last Updated
October 14, 2022
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05577637
Brief Title
Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo
Official Title
Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate.
Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone.
Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation.
The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Phototherapy, tacrolimus, vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A topical tacrolimus 0.03% with uvb phototherapy
Arm Type
Active Comparator
Arm Description
Group A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks
Arm Title
Group B topical placebo twice daily with uvb phototherapy thrice weekly
Arm Type
Active Comparator
Arm Description
Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Other Intervention Name(s)
ointment eczemus
Intervention Description
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Primary Outcome Measure Information:
Title
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
Description
repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients having 20-60 years of age
non pregnant
no history of photosensitivity
no history of immunosuppression or immunosuppressive drugs
no histry of steroids use oral or topical in last four weeks
Exclusion Criteria:
pregnancy
lactation
history of photosensitivity
photo-aggravated dermatoses
history of any immunosuppressive disorder or use of immunosuppressive medicine
history of using steroids either oral or injectable within the previous one month
history of skin malignancy
Facility Information:
Facility Name
cmh Abbottabad
City
Abbottabad
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22020
Country
Pakistan
12. IPD Sharing Statement
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Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo
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