Role of Tofacitinib in Vitiligo Patients

NCT05293119 | Unknown Early Phase 1 DMC

• 1 other identifier: Pircc-1026
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Standard treatment for vitiligo often has unsatisfactory outcomes. With a new understanding of pathogenesis, novel drugs have been introduced which have shown to be effective in small-scale studies. Tofacitinib, a Janus kinase(JAK) inhibitor-2 has shown promising results in the treatment of vitiligo. However, randomized controlled studies are required to confirm these observations and identify the patients most likely to benefit from JAK-2 inhibition. This open-labeled randomized clinical trial will be conducted at the department of dermatology and venereology of US Bangla Medical College \& Hospital in Dhaka for 6 months duration from June 2021 to November 2021 to Vitiligo patients attending in the aforementioned department will be approached for inclusion in the study. Finally, 80 patients who will fulfill the inclusion and exclusion criteria will be included. All patients will be informed about the nature of the study and the written consent will be taken in the consent form with the assurance that their information will be made confidential. Baseline information such as gender, age, disease history, and drugs used prior will be collected. All patients will undergo baseline laboratory evaluation which will be repeated at 6weeks and 12weeks. Before the beginning of treatment, digital images of the cutaneous lesions will be taken which will be compared with the ones taken at 6weeks and the end of 12weeks follow up. The participants will undergo randomization into 1:1 ratio into two equal groups. Group A will receive oral Tofacitinib and Group B will receive topical 0.1%Mometasone furoate. All the participants will receive allotted intervention for 12weeks. The patient will be followed up at 6 weeks and end of 12 weeks. The primary outcome of the study will be the improvement of the Vitiligo Area Scoring Index (VASI) score at 6 and12 weeks in all groups. Secondary outcomes will include improvement in Vitiligo European Task Force (VETF) scoring. The data will be systematically described and summarized and presented through descriptive statistics and finally will be analyzed by the statistical program Statistical Package for Social Science (SPSS) version 23.0(Chicago, Illinois, USA). The relevant statistical test will be used during the analysis. In all cases, the significance level will set p \<0.05. Ethical clearance of the study will be obtained from the ethical review committee (ERC) of the study place.

Conditions

Vitiligo; Effect of Drug

Keywords

Vitiligo; Tofacitinib; Dermatology; Skin

Outcome Measures

Primary Outcomes (2)

• Change in the VASI at 6 weeks.

  The primary outcome will be a change in the VASI score at 6 weeks

  6 weeks

• Change in the VASI at 12 weeks

  The primary outcome will be a change in the VASI score at 12 weeks

  12 weeks

Secondary Outcomes (2)

• Change in Vitiligo at 6th week by Vitiligo European Task Force scoring

  6 weeks

• Change in Vitiligo at 12th week by Vitiligo European Task Force scoring

  12 weeks

Study Arms (2)

Tofacitinib

EXPERIMENTAL

In this group, study participants will be treated with per oral tofacitinib citrate (5 mg/twice daily)

Drug: JAK-2 inhibitor

Topical corticosteroid

ACTIVE COMPARATOR

In this group, patients will apply topical Mometasone furoate 0.1% once daily

Drug: Topical corticosteroid

Interventions

JAK-2 inhibitor DRUG

In this trial, one group will receive the tofacitinib 5 mg twice daily

Also known as: Tofacitinib

Tofacitinib

Topical corticosteroid DRUG

Mometasone furoate 0.1% ointment once daily

Also known as: Mometasone furoate 0.1%

Topical corticosteroid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Vitiligo patients
• Willing to participate

You may not qualify if:

• Age \<18 years
• Patients with leukoderma secondary to other causes
• Participants with segmental or universal vitiligo
• Rapidly spreading vitiligo
• Lesions on areas known to be recalcitrant to therapy such as mucosal vitiligo
• Participants with a history of skin cancer
• Radiotherapy use
• Photosensitivity
• Women who are pregnant, breastfeeding or likely to become pregnant during the 9-month treatment period;
• Those currently using immunosuppressive drugs
• Involved in another clinical trial
• Not willing to participate

Sponsors & Collaborators

• Pi Research Consultancy Center, Bangladesh: lead

MeSH Terms

Conditions

Vitiligo

Interventions

tofacitinib; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mohammad Jahid Hasan, MPH

  Pi Research Consultancy Center, Dhaka, Bangladesh

  STUDY CHAIR

Central Study Contacts

Md. Rashidul Hasan, FCPS, DDV

CONTACT

01921846368; hasanrashidul1981@gmail.com

Mohammad Jahid Hasan, MPH

CONTACT

+8801757818973; dr.jahid61@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will undergo randomization into 1:1 ratio into two equal groups. Group A will receive oral Tofacitinib and Group B will receive topical 0.1%Mometasone furoate. All the participants will receive allotted intervention for 12weeks. The patient will be followed up at 6 weeks and end of 12 weeks. Primary outcome of the study will be improvement of Vitiligo Area Scoring Index (VASI) score at 6 and12 weeks in all groups. Secondary outcomes will include improvement in Vitiligo European Task Force (VETF) scoring.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: March 24, 2022
• Study Start: May 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share