CTRI Number |
CTRI/2023/07/055546 [Registered on: 24/07/2023] Trial Registered Prospectively |
Last Modified On: |
21/07/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of efficacy of 5-FU cream and methotrexate gel in acral vitiligo lesions |
Scientific Title of Study
|
A split-body study to compare the efficacy of combination of CO2 laser and topical methotrexate 1% versus CO2 laser and 5-fluorouracil 5% in stable acral vitiligo. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vishal Thakur |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
Address |
Department of Dermatology,
All India Institute of Medical Sciences, Bhubaneswa, Orissa, India
Khordha ORISSA 751019 India |
Phone |
9878576002 |
Fax |
|
Email |
drvishal87igmc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vishal Thakur |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
Address |
Department of Dermatology,
All India Institute of Medical Sciences, Bhubaneswa, Orissa, India
Khordha ORISSA 751019 India |
Phone |
9878576002 |
Fax |
|
Email |
drvishal87igmc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vishal Thakur |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
Address |
Department of Dermatology,
All India Institute of Medical Sciences, Bhubaneswa, Orissa, India
Khordha ORISSA 751019 India |
Phone |
9878576002 |
Fax |
|
Email |
drvishal87igmc@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences, Bhubaneswar, Odisha |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bhubaneswar Odisha |
Address |
All India Institute of Medical Sciences Bhubaneswar, Odisha- 751019 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Vishal Thakur |
All India Institute of Medical Sciences, Bhubaneswar, Odisha |
Room no. 135, Skin OPD,Department of Dermatology,
All India Institute of Medical Sciences, Bhubaneswar, Orissa, India-751019 Khordha ORISSA |
9878576002
drvishal87igmc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
5-fluorouracil 5% cream |
5-fluorouracil 5% creamonce daily for 7 days will be applied over the patches of vitiligo after Fractional CO2 Laser. |
Intervention |
Methotrexate 1% gel |
Topical methotrexate 1% gel once daily will be applied over the patches of vitiligo after Fractional CO2 Laser. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Age>18 years
2. Patients with stable acral or acrofacial vitiligo and nonsegmental vitiligo having bilateral symmetrical lesions.
3. Two independent areas of size at least 1 x 1 cm or a single lesion with minimal size of at least 2 x 2 cm.
4. Patients who have not undergone any surgical management for the vitiligo. |
|
ExclusionCriteria |
Details |
1. Patients with active vitiligo with signs of active vitiligo like confetti- like depigmentation, new lesions in the surrounding area, or the extension of existing lesions in the last 12 weeks.
2. History of keloidal tendency/hypertrophic or keloidal scarring
3. Collagen vascular disease and bleeding disorders
4. Any active bacterial, fungal or viral infection over the lesional site
5. Pregnant and lactating females
6. Age less than 18 years
7. Patients on anticoagulant therapy or aspirin
8. Patients with an unrealistic expectation |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months. |
5 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Time to achieve a 50% reduction in lesional VASI from baseline.
• Proportion of patients achieving 75% reduction in lesional VASI from baseline at five months.
• Time to achieve a 75% reduction in VASI from baseline.
• Patient satisfaction using Patients’ global assessment score.
• Adverse events, if any. |
5 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/08/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvishal87igmc@gmail.com].
- For how long will this data be available start date provided 13-07-2023 and end date provided 13-06-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIl.
|
Brief Summary
|
Vitiligo is a common acquired, depigmenting skin disease that affect the patient’s psychological state and quality of life. Acral vitiligo is often refractory to treatment as compared to vitiligo at non-acral sites. Several modalities are available for treating acral vitiligo, but none are completely satisfactory. Recently, fractional carbon dioxide (CO2) laser has been introduced as an add-on treatment for vitiligo. Fractional CO2 laser acts by stimulating the release of cytokines and growth factors that act as mitogens for melanogenesis. Also, microscopic ablative zones produced by it promotes the trans-epidermal penetration of topical agents, providing additional benefits for repigmentation. Ablative fractional laser-assisted delivery of topical 5-fluorouracil (5-FU) has been used in vitiligo in several studies with good results, and the combination of CO2 laser and 5-FU has been recommended for the treatment of acral vitiligo by the British Association of Dermatologists Guidelines.1 Recently, topical methotrexate 1% gel was used in a case report of vitiligo and was applied to a single patch twice daily for 12 weeks with significant improvement in pigmentation without local or systemic side effects during the course of therapy. Thus, it may prove to be an important steroid-sparing agent in the treatment of vitiligo. As methotrexate is a large, hydrophilic molecule that does not penetrate intact skin, several drug delivery systems are being developed such as, nano-vehicle preparations and laser-assisted delivery. One study has evaluated fractional Erbium laser-assisted delivery of topical methotrexate in porcine skin and found that methotrexate distribution and concentration in the mid-dermis was facilitated by ablative fractional laser, suggesting that ablative fractional laser-assisted topical methotrexate-delivery may be an appropriate alternative to systemic methotrexate for some skin disorders. |