INTRODUCTION
The primary purpose of the skin is to be a protective permeability barrier interfacing between the dry air environment and our endogenous aqueous environment. The result of damaging environmental and therapeutic insults of any cause are a disrupted stratum corneum barrier coupled with epidermal and dermal chronic inflammation.3,4,5,6 A disrupted stratum corneum barrier itself activates chronic inflammation, but also leads to heightened skin sensitivity, increased permeability to pollutants, contact irritants and sensitizers and UV-R. This increased penetration enhances the number of oxidation reactions and frequency of DNA damage. 6,7 Furthermore, anti-inflammatory and anti-oxidants such as retinol/retinoids, certain hydroxy acids and even therapeutic corticosteroids and topical drug vehicles like propylene glycol at least transiently thin the stratum corneum, induce epidermal atrophy and release de novo stratum corneum pro-inflammatory biologic response modifiers including tumor necrosis factor alpha.8,9
Repairing a damaged stratum corneum barrier, and then optimizing it, while minimizing and preventing destructive chronic inflammation, would thus be expected to lead to improvements in the signs and symptoms of skin photoaging.10 The six clinical trials of 110 subjects discussed in this paper were performed to demonstrate the superiority of this concept over the most commonly used antiaging molecules as well as provide proof of this new concept.
MATERIALS AND METHODS
The novel cosmeceutical blend (NCB) regimen tested here consists of three products utilizing 11 herbal extracts. The primary NCB product, which is used in five of these trials, contains extracts of date palm fruit, meadowfoam, flax, apple, rose hip, avocado and safflower. A second product—NCB companion—contains extracts of willow bark and castor bean along with lower concentrations of date, meadowfoam, flax, rosehip and apple is used in two trials. The third product, NCB variation, which also included two peptides plus ursolic acid and azelaic acids, is used in one trial. All test products used were manufactured by Episciences, Inc. of Boise, Idaho, owned by author Thornfeldt. All of the eleven herb extracts used in these products are listed in Table 1.
These trials were conducted by a nationally prominent contract clinical research group, which employs author Rizer using a randomized split face design in a prospective, double-blind methodology with placebo or approved prescription product as control. All six trials had institutional review board (IRB) approval. The statistical analysis used paired t-test to compare
