Abstract
Background/Purpose: In the frame of a development of a formulation to be used in perineal massage in pregnant women, a screening program was built up among compositions with elasticising properties. Methods: This was an open-label, controlled study in 21 volunteers. The participants applied once, on the volar surface of both forearms, five formulations with elasticising properties (test products 1 to 5) and a reference standard (test product 6). The formulations were applied on three sites on each forearm that were randomly assigned. Skin elasticising parameters were evaluated using the Dermal Torque Meter, at baseline and 30 minutes after application. Results: Among the test products, only test product 2 significantly increased skin elasticity compared with the baseline value, with a trend toward superiority versus the reference standard (+24% vs. +13%, respectively). There was a significant increase in elastic recovery of 23% with test product 2, compared with a significant increase of 13% with the reference standard. Conclusion: Test product 2, comprising a thiolated compound and a mixture of esters of fatty acids, had the greatest elasticising effect. Compared with the other tested formulations, product 2 led to a greater increase in extensibility and faster elastic recovery of the skin on the volar surface of the forearm.
Highlights
The sponsor developed a composition directed to improve tissue elasticity, in order to prevent lacerations during delivery
A significant increase of 23% was recorded for test product 2, with mean ± SD Ur/Ue 0.596 ± 0.097 and 0.735 ± 0.147 at baseline and 30 minutes after application, respectively (p < 0.001 Student’s t test)
Our results show the elasticising properties of test product 2 in terms of increased extensibility and faster elastic recovery, on the volar forearm surface after application
Summary
The sponsor developed a composition directed to improve tissue elasticity, in order to prevent lacerations during delivery. The first step concerned the selection of a non-pharmaceutical product able to improve the elasticity of the skin. In order to investigate the biomechanical and elasticizing properties of the composition, it set up a screening program aiming to find a new medical device acting through a physical mechanism. The lubricating and moisturizing properties of paraffin are well-known [1], as those of fats, including the esters of glycerol and those of animal or vegetable steroids [2]. In the field of such discovery, a number of compositions were prepared, containing thiolated compounds and/or a mixture of esters of fatty acids, antioxidants and glycerol, with the aim to find a “lead” with maximum elasticising, soothing and lubricating properties. Thiols have been chosen for their capability, by reducing the S-S bonds, to modify the quaternary composition of proteins [3] and to allow their extension, preventing stretching traumas
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