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Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo

Sponsor
Combined Military Hospital Abbottabad (Other)
Overall Status
Completed
CT.gov ID
NCT05577637
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group A topical tacrolimus 0.03% with uvb phototherapy

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

Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Other Names:
  • ointment eczemus

    		•
    Active Comparator: Group B topical placebo twice daily with uvb phototherapy thrice weekly

    Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks

    Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
    0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
    Other Names:
  • ointment eczemus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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} [12 weeks]

      repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 cmh Abbottabad Abbottabad Khyber Pakhtunkhwa Pakistan 22020

    Sponsors and Collaborators

    • Combined Military Hospital Abbottabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rohida Rahmat, principle investigator, Combined Military Hospital Abbottabad
    ClinicalTrials.gov Identifier:
    NCT05577637
    Other Study ID Numbers:
    • CMHAtd-26-Derm-22
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rohida Rahmat, principle investigator, Combined Military Hospital Abbottabad
    Phototherapy
    tacrolimus
    vitiligo
    Additional relevant MeSH terms:
    Vitiligo
    Tacrolimus

    Study Results

    No Results Posted as of Oct 17, 2022