Clinical trial NCT05577637: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vitiligo
Keywords: Phototherapy
tacrolimus
vitiligo
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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}
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: cmh Abbottabad
state: Khyber Pakhtunkhwa
Study officials:
References: