with psychologically distressing skin conditions.
Dermatology
Our Work In Dermatology
The global prevalence of this condition has increased from 0.5%-3%, equally affecting individuals of all ages, races and genders. This devastating disease of the skin has both psychological and physical effects on the patient resulting in low self-esteem and fear of social stigma.
An increasing number of reports indicate the usefulness of combination treatments for vitiligo. These target the immune system and improve melanocyte proliferation. This combined approach may reduce potential side effects of each treatment, improving the overall effectiveness and the time needed to achieve repigmentation.
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.
First degree: affecting the superficial layer of the skin
Second degree: extending beyond the superficial layer affecting both, the epidermis and the dermis
Third degree: extending beyond the dermis causing nerve damage.
Composition and mechanism of action
It is a small, novel, topical, synthetic antimicrobial lytic peptide made of 23 amino acids with a molecular weight of 2775.42.
The anti-bacterial activity of the drug is carried out by direct pore formation leading to cell lysis of gram positive and gram negative bacteria. It stimulates growth of fibroblasts and keratinocytes, thereby exhibiting proven wound healing properties with no scar formation.
Preclinical and clinical trials
In-vitro studies of the drug on bacterial cells with a concentration of 0.5% and 0.2% and exposure for 90 minutes have shown disruption and lysis of cell membrane of bacteria. These studies have also demonstrated a definitive effect in promoting proliferation of both fibroblasts and keratinocytes.
The clinical studies were conducted in India in three phases:
Phase 1: open label, randomised, single centre study (n=24)
Phase 2: double blinded, randomized, multi centred, placebo controlled study with Xylentra for efficacy and safety in patients with partial thickness burns (n=120)
Phase 3: double blind, randomized, multicentre study on Xylentra Vs Silver Sulfadiazine for efficacy and safety in patients with partial thickness burns (n=160)
Results and advantages
Xylentra has demonstrated excellent scar reducing effects and contracture formation, showing potential wound healing activity at a very low concentration i.e. 0.5%. It exhibits higher would healing effects when compared with Silver Sulfadiazine as more number of patients showed nil bacteria growth during the study period when compared to SSD 1%.
Xylentra phase 3 trial data was presented at the 17th congress of the International Society for Burn Injuries (ISBI) Pre-Congress workshop on 14th October 2014, Sydney, Australia.
Composition and mechanism of action:
Soriacare® is a novel, non-biologic, non-steroidal, synthetic, small decapeptide consisting of 10 amino acids.
Soriacare® has a dual mechanism of action targeting the Vascular Endothelial Growth Factor (VEGF) and IL 17/23, Soriacare® binds to the VEGF thereby blocking the binding of VEGF to its receptor (VEGFR2), exhibiting anti-angiogenesis and anti-inflammatory action.
Preclinical trials
Based on the in-vitro mechanistic studies in HUVEC cell lines, anti-inflammatory activity was proven by using splenocytes and human monocytes THP-1 and In-vivo studies in Balb/c mice by subcutaneous route of administration in Imiquimod (IMQ) Induced Psoriasis Model.
Results
These results demonstrated that Soriacare® targets VEGFR-2 by down regulating p38 kinases and Pro-inflammatory IL-23 and IL-17 secretion. Considering these factors, the study provides evidence Of possibility to treat inflammatory skin diseases such as Psoriasis by subcutaneous administration of an antiangiogenic compound.
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