Comparison of efficacy of 5-FU cream and methotrexate gel in acral vitiligo lesions

Phase 4

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2023/07/055546
• Lead Sponsor: All India Institute of Medical Sciences Bhubaneswar Odisha

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age>18 years 2.
• Patients with stable acral or acrofacial vitiligo and nonsegmental vitiligo having bilateral symmetrical lesions.
• 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.
• Patients who have not undergone any surgical management for the vitiligo.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months.	5 months

Secondary Outcome Measures

Name	Time	Method
• 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.

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Bhubaneswar, Odisha; 🇮🇳 Khordha, ORISSA, India

All India Institute of Medical Sciences, Bhubaneswar, Odisha

🇮🇳Khordha, ORISSA, India

Vishal Thakur

Principal investigator

9878576002

drvishal87igmc@gmail.com