A Prospective, Open-Label Non-Randomized Clinical Trial to evaluate the safety and efficacy of Pigmento Tablet & Ointment in treatment of Vitiligo
Abstract
Background: Vitiligo is a chronic dermatological condition characterized by the loss of skin pigmentation due to the destruction or dysfunction of melanocytes. It can affect individuals of all ages, genders, and ethnicities, often leading to psychological and social distress due to its visible impact on appearance. Recent research into alternative therapies and repurposed treatments has gained momentum, offering potential for improved outcomes. However, well-structured clinical trials are essential to validate these therapies. PIGMENTO Tablet & Ointment, are polyherbal formulations manufactured by Charak Pharma Pvt. Ltd., and were evaluated for its efficacy and safety in patients with vitiligo. A total of 300 patients were included in the study to assess the impact of this treatment approach.
Materials & Methods: This phase 3, non-randomized, prospective, multi-centric, open-label clinical trial aimed to evaluate the clinical efficacy and safety of PIGMENTO Tablet & Ointment in managing vitiligo in patients aged 18–60 years diagnosed with depigmented skin patches.
Observation: This clinical trial evaluated the efficacy and safety of Pigmento Tablet and Ointment in 300 vitiligo patients (mean age: 36.7 ± 11.2 years, disease duration: 7.8 ± 6.0 years). The study demonstrated significant re-pigmentation and disease control over three months, with a reduction in affected body surface area (BSA) from 40.2% ± 18.4% to 25.4% ± 15.3% (p = 0.001). Lesion visibility, size, and spread improved notably, alongside a decline in disease activity (p < 0.05). Patients reported relief from symptoms like itching and burning (p = 0.012) and enhanced skin resilience (p = 0.009).
Result: Pigmento Tablet and Ointment demonstrated significant clinical benefits in vitiligo management, including reduced lesion extent, improved appearance, slower disease progression, and enhanced physical and emotional well-being. The therapy was well-tolerated, promoting effective and safe re-pigmentation by stimulating melanogenesis, reducing oxidative stress, and addressing immune-related disruptions. These findings establish Pigmento as a promising and reliable option for improving skin health in vitiligo patients.
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References
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