Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05293119 |
| Other study ID # |
Pircc-1026 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2022 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Pi Research Consultancy Center, Bangladesh |
| Contact |
Md. Rashidul Hasan, FCPS, DDV |
| Phone |
01921846368 |
| Email |
hasanrashidul1981[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
Clinical and demographic information, including sex, age, Fitzpatrick type of skin, disease
duration and course, medical history, family history and prior treatment will be collected.
Baseline laboratory testing (complete blood count, liver function tests, renal function test,
basic metabolic panel, hepatitis B/C panel, Tuberculosis and HIV screening) will be
performed.
Baseline Vitiligo Area Scoring Index (VASI) score:
Hamzavi et al.19 have introduced a quantitative parametric score, named VASI for Vitiligo
Area Scoring Index. The total body VASI is calculated using a formula that includes
contributions from all body regions (possible range, 0-100) Total Body surface area (BSA)
will be calculated with the use of a handprint (palm plus the volar surface of fingertips) to
estimate 1% BSA. Multiplication of affected BSA (estimated with the use of hand units) by the
degree of depigmentation (0-100%) within each hand unit will be performed to calculate a VASI
score.
Baseline Vitiligo European Task Force(VETF) scoring:
Baseline extent of disease, staging, and spread will be measured according to Vitiligo
European Task Force scoring tool.
Digital images of the cutaneous lesions, both with normal ambient light and with Wood's lamp,
will be obtained before the treatment beginning and at 6 weeks and 12 weeks(at the end of
study).
Washout of previous treatment:
Patients with recent vitiligo treatment exposure will be required to wash out of treatment
within designated time frames (topical treatment, 2 weeks; immunomodulating oral medications,
4 weeks; laser and light treatment, 8 weeks; and investigational/biologic therapies, 12
weeks). Patients will be asked to refrain from using other vitiligo treatments throughout the
duration of the trial.
Confidentiality:
Trial data and individual participants' medical information obtained as a result of this
study is considered confidential. Participant confidentiality will be ensured by using
identification code numbers to correspond to treatment data in the computer files and on
trial photographs.
Participant timeline Participants are enrolled in the trial for 6 months. During this period,
participants attend a hospital outdoor at baseline for recruitment, medical photography,
photo-sensitivity assessment (minimum erythema dose (MED) test) and followed by assessment at
6 and 12 weeks for compliance and outcome.
Randomization and blinding
Participants are randomized to one of two treatment groups in a ratio of 1:1 where each group
has equal opportunity to receive any treatment option as follows:
Tofacitinib group (Group A) Topical corticosteroid group (Group B) After all eligibility
criteria have been confirmed and medical photographs taken, participants are randomized by
lottery. Participants, principal investigators, members of trial management group and data
analysts are not blinded to treatment allocation.
Interventions:
Tofacitinib: (Group A) Treatment with oral tofacitinib citrate, will be initiated with, 5mg,
twice daily. It is associated with infections, malignancies, cytopenias, gastrointestinal
perforations and hyperlipidaemia in some patients with rheumatoid arthritis.
Topical corticosteroid: (Group B) Mometasone furoate 0.1% ointment a potent corticosteroid
used once daily, has been recommended in the European Clinical Guidelines for the management
of vitiligo. In order to minimize the risk of adverse reactions, the Guidelines recommend a
discontinuous regimen involving periods of use followed by break periods. Possible adverse
reactions to mometasone furoate 0.1% include: infection, folliculitis, paraesthesia, burning
sensation, contact dermatitis, skin hypopigmentation, hypertrichosis, skin striae, acneiform
dermatitis, skin atrophy, pruritus, application site pain and visual disturbance.
Participants are advised to stop treatment with the ointment if they notice any side effects
and to contact the local research team for review and advice on when to restart treatment.
Adherence:
Adherence is recorded in a treatment diary, which acts as a record to inform clinic
appointment questions about the number of ointment applications undertaken since the last
clinic visit. Collection of these data at each clinic visit (every 6weeks) also helps to
check participants' understanding of treatment and to encourage adherence; additional
training is provided at the clinic visit if it has been noticed the participant is not using
the device appropriately or has misunderstood the treatment schedule.
Treatment modification following adverse events:
Participants are instructed to record adverse events in their treatment diaries and to
contact their recruiting center if they experience side effects of concern, or a serious
adverse event (whether related to the trial treatment or not). For treatment-related side
effects, or drug-induced photosensitivity, the research team provides telephone advice or
arrange for a dermatology consultation, as necessary. Treatment modifications, including
reduction or suspension (temporary or permanent) of either oral tofacitinib, topical
corticosteroid at the discretion of the dermatologist, as appropriate.
In case of a medical emergency where an active treatment of the oral drug or the device would
need to be stopped, active treatment of both interventions should be assumed.
Data collection and management:
Data collection and skin assessments will be undertaken by the investigators at the
recruiting hospital. Participants will be assessed end of6 weeks and 12 weeks with
observation of improvement in regards to re-pigmentation, extent of disease, staging, and
spread. Photographs of the lesion will be taken during each visit and the participants will
be inquired and examined to find out side effects of the interventions. Participants who do
not attend clinic visits at 6 weeks and 12 weeks continue to be invited to subsequent
follow-up visits unless they decline further participation in the trial. Laboratory testing
(complete blood count, liver function tests, renal function test, basic metabolic panel will
be performed at 6 weeks and 12 weeks.
Outcomes:
Primary outcome:
The primary outcome will be improvement in the VASI 6 weeks and 12 weeks. Multiplication of
affected BSA (estimated with the use of hand units) by the degree of depigmentation (0-100%)
within each hand unit was performed to calculate a VASI score (possible range, 0-100).
Secondary outcome:
Secondary outcomes included improvement in Vitiligo European Task Force scoring. The Vitiligo
European Task Force is a validated tool that grades vitiligo on extent of disease, staging,
and spread. Extent of disease is calculated by use of the "rule of nine" to estimate BSA,
staging is assessed through degree of depigmentation on a 0 (no depigmentation) to 4
(complete depigmentation) scale, and spread is scored on a simple scale (+1: progressive; 0:
stable; -1: regressive).
Withdrawal of study participants:
Participants are free to withdraw from the study at any point, for any reason. If this
occurs, the primary reason for withdrawal will be documented in the participant's case record
form. The participant will have the option of withdrawal from:
- Study medication with continued study procedures and collection of clinical and safety
data,
- All aspects of the trial but continued use of data collected up to that point
- All aspects of the trial with the removal of all previously collected data, or
- All aspects of the trial with the removal of previously collected data and stored
participant samples Randomized patients who wish to withdraw from the study before they
have undertaken any study-related procedures will be replaced. Data on the original
participant will be kept on the case record form (CRF)/database if the participant
agrees to this.
Storage:
Drugs will be stored at room temperature 20-250 in trial storage room. Reconstituted solution
with Bacteriostatic water for injection will also be kept at temperature 20-250.
Prohibited Medications: Any interventions for vitiligo, beside those provided in the trial
are specifically prohibited.
