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A Multi-Center, Double-Blind, Randomized, Comparator Controlled Trial Evaluating Topical Formulations for Skin
Journal of Drugs in Dermatology : JDD
|December 4, 2024
Summary
A new study shows ReFORM & RePAIR COMPLEX (R&R) with TriHex Technology significantly improves skin health in Dermatoporosis patients. R&R demonstrated superior results in reducing skin fragility and improving atrophic skin compared to a ceramide moisturizer over 24 weeks.
Area of Science:
- Dermatology
- Skin Biology
- Extracellular Matrix (ECM) Research
Background:
- Dermatoporosis (DP) is characterized by chronic ECM degradation, leading to skin atrophy and fragility.
- A novel product, ReFORM & RePAIR COMPLEX (R&R) with TriHex Technology, aims to enhance ECM recycling and component replenishment.
- This study investigated R&R's efficacy against a ceramide moisturizer for DP management.
Purpose of the Study:
- To evaluate the efficacy of R&R compared to a ceramide moisturizer in treating Dermatoporosis.
- To assess the reduction of purpura events and improvement of atrophic skin over a 24-week period.
- To analyze changes in skin barrier function, hydration, and structural integrity.
Main Methods:
- A 24-week, double-blind, split-arm study comparing R&R to a ceramide moisturizer applied twice daily.
- Utilized standardized photography, skin biopsies, skin barrier function tests (TEWL), LC-OCT, and ultrasound imaging.
- Blinded investigator assessments and participant global improvement questionnaires were employed.
Main Results:
- R&R treatment led to statistically significant improvements in all evaluated skin parameters compared to baseline.
- R&R showed superior TEWL recovery and greater mean improvements than the ceramide moisturizer.
- Ultrasound and LC-OCT imaging revealed significant improvements in rete pegs and dermoepidermal junction (DEJ) undulation with R&R treatment (83% vs. 17%).
- Histological analysis indicated enhanced collagen formation and elastin changes in R&R-treated skin, with improved resilience and reduced bruising.
Conclusions:
- The dermoepidermal junction (DEJ) is the initial anatomical site showing improvement in Dermatoporosis with R&R treatment.
- R&R significantly improved skin functionality, texture, and histological markers of skin health compared to the comparator.
- The findings support the use of R&R for managing Dermatoporosis, addressing ECM degradation and improving skin structure and resilience.
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