Efficacy of Tofacitinib in Vitiligo-a Randomized Controlled Trial in a Selected Tertiary Level Hospital in Dhaka
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Change in the VASI at 6 weeks.
Study Overview
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.
Detailed Description
Participant selection:
All vitiligo irrespective of the duration of the disease presenting at the outpatient department will be initially approached for inclusion in the study. Eighty patients who will fulfillthe inclusion criteria will be recruited inthe study. The patients will be briefed about the aim, objective and details of the procedure the study.
Consent & recruitment:
Participant information sheets will be provided for all trial participants, and ample opportunity is given to discuss the study with the investigator before agreeing to take part. All participants will provide written informed consent for participation, retention and use of the trial data by members of the research group (use of the trial photo-graphs for further research or trial reporting is optional).
Baseline information:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Vitiligo patients
- •Willing to participate
Exclusion Criteria
- •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
Arms & Interventions
Tofacitinib
In this group, study participants will be treated with per oral tofacitinib citrate (5 mg/twice daily)
Intervention: JAK-2 inhibitor (Drug)
Topical corticosteroid
In this group, patients will apply topical Mometasone furoate 0.1% once daily
Intervention: Topical corticosteroid (Drug)
Outcomes
Primary Outcomes
Change in the VASI at 6 weeks.
Time Frame: 6 weeks
The primary outcome will be a change in the VASI score at 6 weeks
Change in the VASI at 12 weeks
Time Frame: 12 weeks
The primary outcome will be a change in the VASI score at 12 weeks
Secondary Outcomes
- 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)