Products – Human

Natural Calcitriol

Genova Derma preparations containing Natural Calcitriol from Cestrum diurnum extract have been shown to be highly effective in relieving inflamed, dry, scaly lesions as seen in Psoriasis, Dandruff and Seborrhea. They are beneficial in the repair of sun and cold damaged skin and specially Psoriasis.

Psoriasis is caused by cells in the outer layer of skin multiplying faster than normal. This causes the older and dead skin cells to build up on the surface of skin, causing the red, scaly patches. Calcitriol works by slowing this overproduction and causing the maturation of skin cells which eases the inflamed, scaly areas. It is similar to vitamin D, which is a vitamin essential for healthy skin.

Calcitriol is used to treat plaque psoriasis – this is the most common type of psoriasis. It is a condition where red scaly patches develop on your skin, called plaques. The most common areas affected are over your elbows and knees, the scalp, the lower part of back, chest and abdomen

Amongst countless cures remedies reliefs poured at the Psoriatics offering panacea, our Anti Psoriasis product boldly steps out of the pack with facts, evidence offering solace from natural science.

Why natural Calcitriol:

  • Several of our current drugs are extracted from natural sources. E.g. Dioxin, Reserpine, Taxol, Artimisinine, Vinca alkaloids and several anti cancer drugs. It has been long established that natural products, in addition to the active molecule (API), contain analogues. that augment the efficacy of the molecule in terms of absorption, utilization and reduction of toxicity.
  • During our safety and efficacy trials done by Dr. Raghu Rama Rao (a leading authority on Psoriasis in AP), it was noted that this product was giving good results in patients who had used other treatments including synthetic product without success. This was the same response from dermatologists who have prescribed this in the last 6 months it has been in the market. It was felt that this increased efficacy was due to the potentiating effect of natural isomers. To validate this observation, a study is being undertaken on a large sample.
  • Patients have particularly reported its lack of irritation when applied on scalp and face.
  • Because the molecule remains in its own environment, it is very stable on the shelf and requires no special storage.
  • For the same reason as above it is more stable against UV light and oxidative degradation. This is particularly of benefit in topical application.
  • It is stable at temperatures above 50 degrees.
  • There is no aqueous process involved and therefore no scope for microbial contamination.
  • Molecule is standardized to a level that it can be analysed and quantified by HPLC against synthetic standard.
  • HPLC against synthetic standard.

Scientific rationale

It has been well researched and established over the last four decades, with multiple clinical trials, that Calcitriol is the most effective treatment for mild to moderate plaque psoriasis. This is also proven to be the best tolerated and least irritant.

Naturally occurring Calcitriol:

It has been known and established for an equally long time that Jay Jasmine/Cestrum diurnum family also are a source of naturally occurring Calcitriol and other D analogues.

Making the connection:

Genova Biotechniques was the first to develop a commercially / industrially viable process of extraction and purification of the active molecule (Calcitriol) from the plant. This was done to an extent that the end extract volume was small enough to be added to any formulation, pure enough to be measured by LCMS and HPLC and suitable for biological assays and applications. Patents were granted for both process and products. All this was done while retaining the molecule in its natural envelop without losing its other benefits.

Safety and efficacy:

Safety, efficacy and compliance study were done which was approved by ethical committee and WHO compliant. The safety and efficacy of the formulations against Psoriasis and some cosmetic applications were clearly established in trials conducted under strict protocols.

This study confirmed that the product is highly effective in mild to moderate Psoriasis and found to be twice as effective as any synthetic alternative. It is also non steroidal. Provides long remission intervals.

Interesting facts emerged proving that the efficacy and stability of the natural molecule to be far greater than its synthetic counterpart. Efficacy was twice as much and stability was more than 4 years as opposed to synthetic molecule which is stable for just 6 months.

Toxicology:

To assure absolute safety of the product, extensive toxicological studies such as Acute oral toxicity, acute dermal abrasion and mutagenicity – salmonella reverse mutation were done at Indian Institute of Toxicology. All of those studies showed absolute safety even with very high doses. Abundant data was collected and compiled in this process.

Significant clearance rates were observed in all of the above conditions. No toxic side effects were noted from systemic absorption in long term use.

Safety and efficacy studies have confirmed the same.

Few of Natural Calcitriol products are Anti Psoriasis ointment & crème, Anti Dandruff Gel & Oil, Sun screen and repair lotion and Heal crack ointment.

Comparison with synthetic product

  • Natural Calcitriol is heat stable at temperatures above 50 degrees
  • It is more stable against UV light and oxidative degradation.
  • Stability of 5 years has been established
  • Synthetic Calcitriol has shorter shelf life and requires overages of 200% to extend shelf life beyond 1 year
  • Natural Calcitriol has synergy with other D derivatives that significantly potentiates the activity
  • Cestrum diurnum extract has anti-microbial, anti-fungal agents and saponins. (Published literature)
  • Efficacy of over 87% in mild to moderate Psoriasis
  • Significantly longer remission times
  • Non steroidal. Safe on Face, Scalp and other sensitive areas.
  • No long term side effects
  • Patients can take control of Psoriasis – Physically, Mentally and Socially.

Safety and Efficacy Study

  • The study was ethical committee approved & WHO compliant
  • Objective:To study the efficacy, safety, and patient compliance of topical Cestrum diurnum extract 1%w/w ointment (Natural Calcitriol) in the treatment of mild to moderate plaque psoriasis
  • Study Period: 01-Feb-2010 to 30-Jun-2010
  • Total no. of subjects inducted into study – 53

Out other products

  • Anti Psoriasis gel
  • Anti Psoriasis cream
  • Anti Psoriasis ointment
  • Anti Dandruff Hair gel
  • Anti Dandruff Hair oil
  • Skin repair cream with sunscreen
  • Heel crack repair cream