A Multi-Center, Double-Blind, Randomized, Comparator Controlled Trial Evaluating Topical Formulations for Skin Fragility of the Arms.

Abstract

Background: Skin atrophy and fragility associated with Dermatoporosis result from chronic extracellular matrix (ECM) degradation. A current marketed product, ReFORM & RePAIR COMPLEX with TriHex Technology® (R&R, Alastin Skincare, Inc.), contains actives that aid in recycling the ECM with new matrix components that have been found to be deficient in patients with DP.1 This study evaluates the efficacy of R&R compared to a ceramide moisturizer for reducing acute episodic purpura events and improving atrophic skin associated with this condition over a 24-week period.

Study design: Participants were evaluated in a double-blind, 24-week split-arm study. Each participant applied R&R to one arm and a ceramide moisturizer on the opposite arm twice daily for 24 weeks. Participants’ arms were evaluated at screening/baseline and follow-up visits at weeks 4, 8, 12, 16, and 24. At all visits, different assessment parameters were evaluated at selected clinical trial centers including standardized photography, skin biopsies, skin barrier function, hydration/transepidermal water loss (TEWL) measurements, line-field confocal optical coherence tomography imaging (LC-OCT), and ultrasound imaging. Efficacy assessments were performed by blinded investigators, and participants completed global improvement questionnaires for each arm. Pre- and post-treatment biopsies were collected for histological evaluation in randomly selected consenting participants.

Results: Thirty-eight (38) participants completed the study, and statistically significant improvements were seen across all arm skin parameters evaluated after 24 weeks of treatment. The R&R treatment arm achieved greater mean improvements and showed substantially better TEWL recovery compared to the ceramide moisturizer treatment arm. Ultrasound analysis revealed improvement in rete pegs and dermoepidermal junction (DEJ) undulation associated with the R&R-treated arm in 83% of study participants compared to the ceramide moisturizer-treated arm (17%). Significantly improved DEJ undulation and strengthening was seen in the R&R-treated arm, which was confirmed by LC-OCT imaging. Histology revealed improved collagen formation in the majority of R&R-treated arm case biopsies, as opposed to the comparator arms, which showed minimal improvements with early changes in elastin formation only evident in the R&R group. In addition, the R&R arms demonstrated more skin resilience and less bruising and skin fragility than the comparator arms.

Conclusion: Dermatoporosis is a condition that takes years to evolve, and recovery is expected to take time. That noted, this study revealed that the DEJ is the first anatomic area to demonstrate improvement in DP status. This was evident in the R&R-treated arms. In addition, skin functionality related to TEWL measurements, overall texture, crepiness, and biopsy changes were all improved to a larger extent in the R&R-treated arms compared to the comparator arms, demonstrating the logical use of R&R for DP management. J Drugs Dermatol. 2024;23(12):1064-1071. doi:10.36849/JDD.8177.