None listed
Conditions
Brief summary
The aim of the present randomized, double placebo-controlled clinical trial was to compare the efficacy of topical application with body lotion enriched with minerals from the Dead Sea (DS) to each of two types of placebo: (1) lotion with no Dead Sea minerals but otherwise identical to DS (Placebo 1) or (2) lotion with no active ingredients (Placebo 2), in reducing symptoms of uremic pruritus (itching, peeling, tightness and dryness) in stable maintenance hemodialysis (HD) patients. Our hypothesis was that DS would be superior to either of the two placebos in reducing these symptoms.
Interventions
Dermud Intensive Nourishing Body Lotion Dry Skin TreatmentDead Sea water and sea silt (Dead Sea mud), which is 46% natural magnesium chloride n the crystalline form. It also contains 2.2% Calcium chloride (CaCl 2) , 0.5% potassium chloride (KCl), 0.8% sodium chloride (NaCl), small amounts of bromides and sulfates These ingredients are listed as humectants together with glycerin, bisabolol and panthenol; isohexadecane, Butyrospermum parkii (shea butter), isopropyl myristate and Hippophae
rhamnoid
Dermud Intensive Nourishing Body Lotion Dry Skin TreatmentDead Sea water and sea silt (Dead Sea mud), which is 46% natural magnesium chloride n the crystalline form. It also contains 2.2% Calcium chloride (CaCl 2) , 0.5% potassium chloride (KCl), 0.8% sodium chloride (NaCl), small amounts of bromides and sulfates These ingredients are listed as humectants together with glycerin, bisabolol and panthenol; isohexadecane, Butyrospermum parkii (shea butter), isopropyl myristate and Hippophae rhamnoides oil as emollients; caprylic/capric triglyceride, stearalkonium hectorite, propylene carbonate, cetyl polyethylene glycol/polypropylene glycol – 10/11 dimethicone and polyglyceryl-4-isostearate as emulsifiers; and Aloe barbadensis leaf juice and sodium lactate as moisturizers. Additionally, the product contains calendula extract, glycerin, butylene glycol, dipotassium glycyrrhizinate, allantoin and calamine as anti-irritants. Participants were instructed to apply topically to the skin of the entire body twice daily and following bathing for a period of two weeks. Patients were randomized to treatment with the active treatment or with one of two placebos, placebo 1 or placebo 2.
Sponsors
Ahava Dead Sea Laboratories and Dead Sea Research Center
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Hemodialysis (HD) patients aged 40-80 years inclusive were eligible for study participation if they received HD treatment three times each week for not less than three months, and if they were willing to refrain from any antipruritic treatment, oral or topical, for a period of not less than two weeks prior to study initiation. Patients of both genders, without regard to comorbidities or prescribed medications, were eligible.
Exclusion criteria
Patient unwillingness to participate for any reason; known sensitivity to any of the ingredients in the active or placebo treatments.
Outcome results
None listed