A Prospective, Randomized, Double-Blind, Split-Face Trial Evaluating the Effects of Pre-Conditioning With a TriHex Technology Serum Nectar 2.0 Versus a Vehicle in Subjects Undergoing Elective Facelift Surgery

Abstract

Background: Preconditioning of skin prior to procedures with the Alastin TriHex Technology has been demonstrated to enhance procedure outcomes. Alastin Regenerating Skin Nectar with TriHex Technology Serum (Alastin Skincare Inc. Carlsbad, CA) has undergone reformulation to include an added Octapeptide-45 for improving post-surgical outcomes and healing through pre-conditioning. A 5-week clinical trial was conducted to demonstrate efficacy and safety for post-surgical skin wound healing (following pre-conditioning), and overall skin health. In particular, molecular and cellular changes were documented, histologically comparing the treated side against the vehicle on the opposite side.

Methods: A randomized, double-blinded, split-face, comparative study was conducted in 5 patients to evaluate the effects of pre-conditioning with a TriHex Technology Serum 2.0 (Nectar 2.0) compared to vehicle in subjects undergoing elective facelift surgery. Patient questionnaires and investigator assessments were undertaken, and baseline biopsies were taken from both sides 4 weeks prior to surgery. Following the facelift surgery, collected skin samples from each side of the face were analyzed for histological changes comparing pre (screening) and post (4 weeks) of pre-conditioning use of study topicals by an independent dermatopathologist using multiple staining techniques.

Results: Investigator assessment with facial aesthetic clinical grading scale demonstrated greater improvements for the Nectar 2.0 treatment side compared to vehicle at Day 7 from screening for all assessed parameters: skin dullness, fine lines, tactile roughness, global photodamage. Investigator healing assessments demonstrated improved Healing on the Nectar 2.0 treatment side compared to vehicle, related to erythema, edema, and crusting parameters. Histological differences between the two sides were significant with major changes in extracellular matrix composition involving collagen, elastin and hyaluronic acid production and reversal of solar elastosis, all Evident only on the Nectar 2.0 treated side.

Conclusion: A randomized, double-blinded, split-face, comparative study with Alastin Regenerating Skin Nectar with TriHex + Technology Serum 2.0 revealed that pre-conditioning resulted in significant improvement in healing, global skin health and histological results with marked remodeling of the ECM being observed in all patients. A short period of pre-conditioning can have substantial effects on skin health and procedure outcomes.