CompletedPhase 3Phase 4ACTRN12610000741088

A comparison of body lotion containing Dead Sea minerals to two body lotions without Dead Sea minerals in the treatment of skin problems in hemodialysis patients

A randomized controlled clinical trial comparing the efficacy of Dead Sea mineral enriched body lotion vs. two types of placebo in the treatment of cutaneous dryness, itching, peeling and tightness in hemodialysis patients: EDIT

Sponsor

Ahava Dead Sea Laboratories and Dead Sea Research Center

Enrollment

75 participants

Start Date

Nov 1, 2007

Study Type

Interventional

Conditions

uremic pruritus

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.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a body lotion containing Dead Sea minerals can help relieve skin problems in people aged 40 to 80 who are on regular dialysis. You must have been on dialysis three times a week for at least 3 months and be willing to stop using other anti-itch treatments for 2 weeks before the study. People with allergies to the lotion ingredients cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(1)

Israel

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ACTRN12610000741088