Bringing hope for a stigma-free experience for patients affected
with psychologically distressing skin conditions.
A maximum number of complaints worldwide, arise due to skin conditions. As per a 2010 Global Disease Burden study, skin diseases were among the top ten widespread diseases and the fourth most frequent cause of non-fatal disease burden worldwide. These conditions have been observed to have the most stigmatising effects on an individual, resulting in low self-esteem and extreme psychological distress.
There is significant escalation in the understanding and application of peptides as therapeutics for skin conditions. Specifically, peptides with antimicrobial properties and those associated with inflammatory processes serve as potential therapeutic agents for conditions like psoriasis, dermatitis, and vitiligo. Cyclic peptides perform a wide range of biological functions and can be modified both synthetically and genetically to improve skin permeability and structural stability. Therefore, they provide excellent drug leads to achieve the desired action.
Composition and mechanism of action
Novoskin® is a decapeptide derived from Basic Fibroblast Growth Factor (BFGF). It is the active fragment that binds to the receptors involved in repigmentation. It consists of 10 amino acids with a molecular weight of 1543.679.
The mechanism of action involves synthesis and multiplication of new melanocytes from the hair follicles and acts as a chemotactic agent directing the melanocytes from the hair follicles/surrounding skin to the vitiligo patch.
Novoskin® is considered to have better results over BFGF as it is a smaller peptide with greater penetration into the epidermis. The vehicle used to dissolve Novoskin® is comprised of three different non polar solvents that help in transporting the peptide into the epidermis which is retained by binding to extracellular matrix heparin sulphate.
Preclinical and clinical trials
Preclinical studies were carried out to assess the safety and efficacy of Novoskin® (topical and intradermal) in producing repigmentation of depigmented patches which was studied in guinea pigs and Yucatan Swine. The results showed increase in the number of melanocytes with no adverse effects.
The clinical trials were carried out in three phases. Phase 1 and 2 demonstrated efficacy in 75% of the volunteers. Phase 3 included three studies which took place over different durations of time.
Study 1: open label, comparative study of 0.1% decapeptide Vs vehicle with UVA exposure
Study 2: conducted in 112 vitiligo patients where Novoskin® was applied in the evening followed by sun exposure in the morning
Study 3: efficacy and safety of Novoskin® in combination with oral minipulse of betamethasone
Study 4: efficacy and safety of Novoskin® in combination with PUVA/PUVASOL
Results and advantages
The results have shown 80-90% response rate when used alone or in combination with other treatment modalities in all types of vitiligo. Specifically, when used with steroids/photo chemotherapy the rate of repigmentation is higher and faster. They have also exhibited a potential to decrease the usage of steroids, thereby decreasing their adverse effects and improving efficacy in patients resistant to PUVA.