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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05577637
Enrollment
60
Registered
2022-10-13
Start date
2021-05-01
Completion date
2021-11-30
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Keywords

Phototherapy, tacrolimus, vitiligo

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.

Interventions

DRUG0.03% 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

Sponsors

Combined Military Hospital Abbottabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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 weeksrepigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026