TransepiŽ Technology Pharmacokinetic Study of Transdermal Vitamin D

Program: Late-Breaking Abstracts
Session: LBSA 0267-0273-Bone, Calciotropic Hormones, & Vitamin D
Translational
Saturday, June 21, 2014: 1:00 PM-3:00 PM
Hall F (McCormick Place West Building)

Poster Board LBSA-0273
Kurt A Josef, B.S.1, Thomas R Bailey, Ph.D.2 and D Craig Wright, M.D.3
1Independent Researcher, Radnor, PA, 2TRBailey Consulting, 3LPJP, LLC
Vitamin D deficiency is at epidemic levels with 1B persons worldwide.   According to the New England Journal of Medicine, 50% of postmenopausal women remain vitamin D deficient in spite of oral supplementation.[1] The American Academy of Dermatology (AAD) does not recommend getting vitamin D from sun exposure (natural) because ultraviolet (UV) radiation can lead to skin cancer.  Transdermal vitamin D delivery mimics physiologic vitamin D production.  A pharmacokinetic study of a novel topical technology (trademarked TransEpi® Technology) was conducted.  The purpose was to demonstrate TransEpi®’s ability to produce a significant increase in vitamin D serum levels and to assess safety.

The 5-week pilot study enrolled healthy subjects (n=6) with screening and baseline blood serum vitamin D levels 25(OH)D less than 30ng/mL.  

The primary endpoint was defined as a numerically significant increase in serum vitamin D levels following 28 days of study product application.  The safety endpoint was the absence of vitamin D excess, i.e., 25(OH)D levels in excess of 1O0ng/mL.  Tolerability endpoint was defined as the absence of skin irritation or cutaneous side effects.

Intent to treat (lowest vitamin D serum level compared to day 35 serum level) demonstrated a mean increase of 26%.  With the lower of screening or baseline vitamin D serum levels as the basis, the study resulted in a mean level increase of 24%. Week 5 vitamin D serum level compared to week 3 demonstrated a mean increase in vitamin D serum levels of 20%.  One subject was excluded for non-compliance. Subjects had increases in Vitamin D levels up to 42%.

The overall patient experience with TransEpi® enabled vitamin D cream was good: 3 mild irritations, possibly study product related, all resolved at the next visit without treatment.  There were no adverse events.

This pharmacokinetic study suggests that TransEpi® Technology provided clinically meaningful increases in Vitamin D blood serum levels with good tolerability.



Disclosure: KAJ: Independent Contractor (including contracted research), Avidas Pharmaceuticals. TRB: Consultant, Avidas Pharmaceuticals. DCW: Clinician, Avidas Pharmaceuticals.

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting

Sources of Research Support: [1]  Holick, M., Vitamin D Deficiency, New England Journal of Medicine (NEJM), July 19 2007
<< Previous Talk | Next Talk