Journal of Clinical and Aesthetic Dermatology - Science of Skin Summit 2025

141—A multi center, open label, full face evaluation of the tolerability and efficacy of REGENX RESTORE GEL formula #RD0104-088 versus control to decrease post-operative recovery in non-ablative fractional laser resurfacing for photodamage

2025-10-29 10:06:55

Presenters: Lain E, Waibel J, Boyd C

Background: Chronic ultraviolet (UV) exposure leads to photodamage, manifesting as epidermal thinning, collagen and elastin fiber disorganization, hyaluronic acid (HA) depletion, and overall structural degradation of the extracellular matrix (ECM). These degenerative changes contribute not only to aesthetic concerns such as wrinkling, dyschromia, and loss of elasticity, but also to increased susceptibility to cutaneous malignancies. Non-ablative fractional resurfacing (NAFR) has emerged as a key therapeutic modality in reversing photoaging, offering a favorable safety profile and stimulating dermal remodeling through microthermal injury. However, postoperative downtime and inflammation remain significant limitations to patient satisfaction and treatment adherence.

Objective: The primary objective of this study was to evaluate the efficacy and tolerability of REGENX RESTORE GEL, a topical formulation containing urodele collagen extract, in reducing post-operative recovery time and enhancing skin healing following full-face 1550 nm NAFR in subjects with moderate to severe photodamage. Furthermore, secondary objectives included assessing improvement in skin appearance parameters—erythema, edema, dryness/flaking, fine lines/wrinkles, and pigmentation irregularities—via a multimodal evaluation approach.

Methods: Quantitative assessments were conducted on a total of 52 subjects, male and female, aged 30 to 70 years, with Fitzpatrick Skin Type from 1 – 6, across 3 sites using the Canfield Gen 5 VISIA CRP (Primos) imaging system at baseline, Day 3, and Week 4. Standardized clinical photography and physician visual assessments were performed at baseline, Day 3, Day 5, Day 7, and Week 4. Subject-reported outcomes were captured through validated questionnaires at corresponding intervals. Additionally, histologic evaluations were performed on preauricular punch biopsies to analyze HA content, elastin and collagen deposition, and epidermal thickness, enabling molecular correlation of clinical outcomes with ECM remodeling.

Results: Histological analysis of skin biopsies at 7 days revealed consistent findings of reduced epidermal atrophy, enhanced de novo collagen deposition, reduced solar elastosis, and features indicative of early dermal remodeling in subjects treated with REGENX RESTORE GEL when compared to baseline pretreatment biopsy results. Expertgraded clinical assessments demonstrated greater improvements in key parameters among subjects treated with REGENX RESTORE GEL compared to the control. Specifically, reductions were observed in erythema (mean reduction of 2.1 points vs. 1.6 in control), and dryness (2.7 vs. 2.4), while global skin quality showed a greater mean improvement (2.7 vs. 2.6). These effects were consistent across all study sites and were independent of age, Fitzpatrick skin type, or gender, supporting the broad applicability and enhanced efficacy of REGENX RESTORE GEL in post-laser recovery.

©Matrix Medical Communications. View All Articles.

141—A multi center, open label, full face evaluation of the tolerability and efficacy of REGENX RESTORE GEL formula #RD0104-088 versus control to decrease post-operative recovery in non-ablative fractional laser resurfacing for photodamage
https://jcad.mydigitalpublication.com/articles/141-a-multi-center-open-label-full-face-evaluation-of-the-tolerability-and-efficacy-of-regenx-restore-gel-formula-rd0104-088-versus-control-to-decrease-post-operative-recovery-in-non-ablative-fractional-laser-resurfacing-for-photodamage

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