FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvishal87igmc@gmail.com].

  6. 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.

  7. 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.

 
Close