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

NCT05577637 | Completed Phase 1

• 1 other identifier: CMHAtd-26-Derm-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

Phototherapy; tacrolimus; vitiligo

Outcome Measures

Primary Outcomes (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}

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

  12 weeks

Study Arms (2)

group A topical tacrolimus 0.03% with uvb phototherapy

ACTIVE COMPARATOR

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

Group B topical placebo twice daily with uvb phototherapy thrice weekly

ACTIVE COMPARATOR

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

Interventions

0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily DRUG

0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily

Also known as: ointment eczemus

Group B topical placebo twice daily with uvb phototherapy thrice weekly; group A topical tacrolimus 0.03% with uvb phototherapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

cmh Abbottabad

Abbottabad, Khyber Pakhtunkhwa, 22020, Pakistan

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: May 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

PA (1)