Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000741088
Ethics application status
Approved
Date submitted
5/09/2010
Date registered
6/09/2010
Date last updated
6/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 252642 0
CRG090800149 Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
EDIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uremic pruritus 243794 0
Condition category
Condition code
Skin 258306 258306 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257145 0
Treatment: Other
Comparator / control treatment
Placebo 1 (P1)was identical to the active treatment but without Dead Sea minerals and sea silt. Placebo 2 (P2) was identical to P1 but contained no moisturizing ingredients (Aloe barbadensis leaf juice or sodium lactate).
Control group
Active

Outcomes
Primary outcome [1] 259154 0
Self-rated severity (rated on a 5-point Likert scale) of cutaneous manifestations of uremic pruritus (itching, peeling, tightness, dryness).
Timepoint [1] 259154 0
Two weeks from initiation of treatment exposure
Secondary outcome [1] 265481 0
Within group self-rated change from baseline severity (rated on a 5-point Likert scale) of cutaneous manifestations of uremic pruritus (itching, peeling, tightness, dryness)
Timepoint [1] 265481 0
Two weeks from initiation of treatment exposure

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unwillingness to participate for any reason; known sensitivity to any of the ingredients in the active or placebo treatments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 2116 0
Israel
State/province [1] 2116 0

Funding & Sponsors
Funding source category [1] 257598 0
Commercial sector/Industry
Name [1] 257598 0
Ahava Dead Sea Laboratories and Dead Sea Research
Country [1] 257598 0
Israel
Primary sponsor type
Commercial sector/Industry
Name
Ahava Dead Sea Laboratories and Dead Sea Research Center
Address
Hatzoref 5
Holon
58856
Country
Israel
Secondary sponsor category [1] 256824 0
None
Name [1] 256824 0
Address [1] 256824 0
Country [1] 256824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259618 0
E. Wolfson Medical Center
Ethics committee address [1] 259618 0
Halohamim 62
Holon
58100
Ethics committee country [1] 259618 0
Israel
Date submitted for ethics approval [1] 259618 0
Approval date [1] 259618 0
22/05/2007
Ethics approval number [1] 259618 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30248 0
Address 30248 0
Country 30248 0
Phone 30248 0
Fax 30248 0
Email 30248 0
Contact person for public queries
Name 13495 0
Dr, Mona, Boaz
Address 13495 0
Director, Epidemiology and Research Unit, E. Wolfson Medical Center, Halohamim 62 Holon Israel 58100
Country 13495 0
Israel
Phone 13495 0
972-3-502-8384
Fax 13495 0
Email 13495 0
[email protected]
Contact person for scientific queries
Name 4423 0
Ms, Larisa, Shtendik
Address 4423 0
Study Coordinator, Institute of Nephrology, Halohamim 62 E. Wolfson Medical Center, Holon, Israel 58100
Country 4423 0
Israel
Phone 4423 0
972-3-502-8284
Fax 4423 0
Email 4423 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.