J Theunis1, H Chaussade2, O Bourgeois2, V Mengeaud1. 1. Skin Research Center, Pierre Fabre Dermo-Cosmétique, Toulouse, France. 2. Private Practice, Saint-Orens de Gameville, France.
Abstract
BACKGROUND:Chronic pruritus, defined as itch persisting more than 6 weeks, is a debilitating problem that affects one in four elderly adults. Emollients are recommended for the management of pruritus, but evidence of efficacy is scarce. OBJECTIVE: Assess the efficacy of a Rhealba® Oat Extract-based emollient in the management of chronic pruritus in elderly outpatients. METHODS: This was a randomized, mono-centric, open-label, cross-over study in adults≥60 years of age with xerosis associated with chronic pruritus. Subjects were randomized 1:1 to start with a 2-week non-treatment phase or a 2-week treatment phase in which they applied the emollient once or twice daily. The primary outcome was subject-assessed pruritus using an established visual analogue scale. Subjects also assessed pruritus using the 5-D itch scale. Investigators assessed xerosis using the Overall Dry Skin Score and measured hydration index by Corneometer® , desquamation by D-Squame and transepidermal water loss by Aquaflux® . RESULTS:Thirty subjects were included. Pruritus intensity on the visual analogue scale improved significantly more during the treatment phase than during the non-treatment phase (P < 0.0001). This was also observed immediately after the first product application (P < 0.0001). According to the 5-D itch scale, pruritus decreased during the treatment phase but remained stable during the non-treatment phase (P = 0.0042). At the end of the treatment phase, more than half of the subjects reported an improvement in pruritus, and 30% reported complete disappearance, whereas pruritus remained stable during the non-treatment phase (P < 0.0001). Xerosis improved significantly more during the treatment phase than during the non-treatment phase as measured by D-Squame, clinical assessment and hydration index (P < 0.0001). Transepidermal water loss did not significantly change. CONCLUSION: Daily use of a Rhealba Oat Extract-based emollient can provide relief to elderly adults who suffer from xerosis associated with chronic pruritus.
RCT Entities:
BACKGROUND:Chronic pruritus, defined as itch persisting more than 6 weeks, is a debilitating problem that affects one in four elderly adults. Emollients are recommended for the management of pruritus, but evidence of efficacy is scarce. OBJECTIVE: Assess the efficacy of a Rhealba® Oat Extract-based emollient in the management of chronic pruritus in elderly outpatients. METHODS: This was a randomized, mono-centric, open-label, cross-over study in adults ≥60 years of age with xerosis associated with chronic pruritus. Subjects were randomized 1:1 to start with a 2-week non-treatment phase or a 2-week treatment phase in which they applied the emollient once or twice daily. The primary outcome was subject-assessed pruritus using an established visual analogue scale. Subjects also assessed pruritus using the 5-D itch scale. Investigators assessed xerosis using the Overall Dry Skin Score and measured hydration index by Corneometer® , desquamation by D-Squame and transepidermal water loss by Aquaflux® . RESULTS: Thirty subjects were included. Pruritus intensity on the visual analogue scale improved significantly more during the treatment phase than during the non-treatment phase (P < 0.0001). This was also observed immediately after the first product application (P < 0.0001). According to the 5-D itch scale, pruritus decreased during the treatment phase but remained stable during the non-treatment phase (P = 0.0042). At the end of the treatment phase, more than half of the subjects reported an improvement in pruritus, and 30% reported complete disappearance, whereas pruritus remained stable during the non-treatment phase (P < 0.0001). Xerosis improved significantly more during the treatment phase than during the non-treatment phase as measured by D-Squame, clinical assessment and hydration index (P < 0.0001). Transepidermal water loss did not significantly change. CONCLUSION: Daily use of a Rhealba Oat Extract-based emollient can provide relief to elderly adults who suffer from xerosis associated with chronic pruritus.