Nitaelis Ltd Report Positive Results from First Clinical Trial with Transdermal Vitamin D3

Rehovot, Israel, - Nitaelis Ltd. Today announced the completion of first phase 3 trial with transdermal Vitamin D3 cream consisting of oil/glycine. The study was carried out on two groups; “Naïve” participants who were not supported by any oral Vitamin D supplement, and participants who regularly kept on Vitamin D supplement. Topical Vitamin D was blinded trial evaluating the safety and efficacy of cream/Vitamin D3 in healthy people.

In the trial, healthy, volunteers were treated for 14 days. During those 14 days each individual was spreading 1gr cream/day (5mg Vitamin D/day) on inside of forearm (limb) area. The participant spread the cream every evening. The participant did not clean the area for at least 6 hours. The outcome results {level of 25(OH)D in serum} of treating (0.5%w/v) Vitamin D3 in oil-in-glycerin emulsions was tested for alleviating deficiency, insufficiency and overdose of Vitamin D.

Among randomized volunteers who received topical 0.5%w/v Vitamin D, after 14 days, the naïve showed average increase of 25(OH)D in blood (at %Δ units) of 5 nmol/L, while the Vitamin D supplement supported group showed average decrease (at %Δ units) of 1.6 nmol/L, both values were found to be significantly different in student t-test.

In the trial of transdermal Vitamin D3, no any local side effects (e.g. irritation, itching, or tickling) but rather highly effective for vitamin D3 in skin penetration (83% of equivalent units from expected 400 IU daily oral intake) were renowned.

Vitamin D is an essential vitamin for healthy skeleton but recently was shown to be involved in many additional diseases. Health authorities in the western world set up a new scale for vitamin D status and circulating levels of 25(OH)D higher than 75 nmol/L is regarded as normal.

“We are very excited about the significant trial’s results that could represent a paradigm that not only provides a new rout of Vitamin D administration, but also a potential for mitigation of 25(OH)D’s blood level. That result successfully mimics effect of Sun-Light,” said Prof. Samuel Edelstein CEO of Nitaelis Ltd.

Nitaelis Ltd is expecting a larger trial involving 35-40 volunteers for 3 months, within the next 12 months. Regulatory submission of transdermal Vitamin D3 in all major markets is expected in 2014 to enable validation of the commercial scale production.

Contact:
Prof. Samuel Edelstein
samueledelstein@walla.com
Tel. +972-54-2344412

Contact Information

Micha VERED

Project Manager

Nitaelis Ltd

(972) 544 707 418

micha@mvered.com