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NCT Number: NCT05577637

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

cmh Abbottabad

Abbottabad, Khyber Pakhtunkhwa, 22020, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ointment eczemus

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}

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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