Management of pruritus sine materia in pregnancy by a dermo-cosmetic spray with anti-itching properties

Approximately 20% of pregnant women have pruritus that leads to a significant discomfort for them all along their pregnancy. During pregnancy, the non-pathological pruritus, eg corresponding to the pruritus sine materia, can be explained by skin dryness and tightness especially on the abdomen due to mechanical strength. The use of an emollient is recommended but moisturizing effect is sometime not enough. The aim of the study is to assess the efficacy and the safety of a specific dermo-cosmetic product with anti-itching properties in pregnant women suffering from pruritus.

33 women (18 to 34 years old) with untreated pruritus sine materia are included in an intra-individual study under dermatological control. The tested dermo-cometic product is a spray that gives a fresh sensation and contains moisturizing agents combined with anti-itching ingredients acting at the origin of the biological itching process. The spray was applied on the affected areas as often as needed with a maximum of 13 pressures per day (each lasting 1 s) for 28 days. The investigator scored from 0 (= absence) to 10 (= severe) the pruritus and dryness intensity at day 0 (D0) and D28. In parallel, the subjects fulfilled the 12-Pruritus Severity Questionnaire (12-PSS) (total score from 3 to 22), the Dermatology Life Quality Index (DLQI) questionnaire (total score from 0 to 30) at D0 and D28, and also evaluated the subjective efficacy and overall appreciation at D28. The product safety was assessed clinically by the investigator and subjectively by the subjects during the study.

The 31 women (average 27 years old, range 18 to 34) who completed the study were mostly multiparous (77%) with phototype III to V (93%) and applied in average 8 pressures per day. At D28, the use of the spray induced a significant decrease of pruritus and dryness, -85% and -90%, respectively, compared to D0 (p<0.001). The 12-PSS score reduced by -26% at D28 vs. D0 (p<0.001), and the quality of life of the pregnant subjects was significantly improved at D28 vs. D0, with a reduction of -68% of the DLQI score (p<0.001). After 28 days, all subjects agreed that the spray soothed pruritus, and their skin presented less tightness feelings. They judged that the spray reduced the urge to scratch (97%), relieved skin irritation (97%) and dryness (94%), was fresh on the skin (81%), and brought comfort and well-being (90%). The skin was healthier (94%), immediately hydrated (90%), more comfortable (84%), and soft to the touch (77%). 97% of the subjects were very satisfied with the product. The spray was safe with no undesirable effects reported after 28-days of use.