Superior Efficacy of an Herbal-based Cosmeceutical Compared With Common Prescription and Cosmetic Antiaging Therapies
February 2016 | Volume 15 | Issue 2 | Original Article | 218 | Copyright © February 2016
Carl R. Thornfeldt MDa and Ronald L. Rizer PhDb
aCT Derm, PC Fruitland, Idaho; and Episciences, Inc Boise, ID
bStephens & Associates Colorado Springs, CO
INTRODUCTION: Research has shown that a disrupted stratum corneum permeability barrier coupled with chronic inflammation induce signs of extrinsic aging (photoaging). An novel herbal-based three product cosmeceutical regimen used to reverse these two anomalies that does not contain retinol, soy, niacinamide, tea, L-ascorbic acid or esters, hydroxy acids, tocopherol, or growth factors was tested in six human clinical trials to determine effectiveness and safety in reversing photoaging.
MATERIALS AND METHODS: Six randomized split face, double blind, prospective, controlled clinical trials involving a total of 110 subjects compared a cosmeceutical blend of novel herbs in regimens consisting of one to three products to several common antiaging topical treatments. These comparative products include prescription tretinoin, physician strength idebenone, kinetin, polyhydroxy, lactic and glycolic acids in reversing signs of photoaging.
RESULTS:The novel cosmeceutical blend regimen showed superior efficacy and safety in all six trials.
DISCUSSION: These trials substantiate that herbs not used in common antiaging products effectively and safely mitigate and reverse photoaging signs and symptoms. The novel concept of treating photoaging and preventing its progression by repairing and optimizing the stratum corneum barrier, while reversing and inhibiting chronic cutaneous inflammation, has now been proven. J Drugs Dermatol.
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