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The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients

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ClinicalTrials.gov Identifier: NCT01651559
Recruitment Status : Unknown
Verified November 2012 by Ahava Dead Sea Laboratories.
Recruitment status was:  Enrolling by invitation
First Posted : July 27, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Ahava Dead Sea Laboratories

Study Description
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Brief Summary:
This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left right comparison will be made, after using the study product and the placebo, for 8 weeks, twice daily, on each of the body sides (left right). In addition to the clinical evaluations, skin biochemistry will be studied using non-invasive techniques. The latter will be correlated with the clinical results of the patients. These will serve for future development of diagnostic assays and personalized therapies.

Condition or disease
Psoriasis Vulgaris

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Double Blind Controlled Clinical Trial Comparing The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients Undergoing Phototherapy
Study Start Date : November 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Psoriasis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. change from baseline of PASI (Psoriasis Area and Severity Index) [ Time Frame: 8 weeks ]

    Grade 2 lesions (left and right- each one assigned a different treatment: study product or placebo)as follows:E=Erythema (redness) I=Induration (thickness) D=Desquamation (scales)

    0 = Absent

    1. = Slight
    2. = Moderate 3= Severe

    4 = Very severe sum the result: modified PASI=E+I+D (in absence of all 3 symptomes the PASI equals 0, if all 3 are very severe then it equals 12.



Secondary Outcome Measures :
  1. change from baseline of the Skin Hydration level [ Time Frame: 8 weeks ]
    corneometric measurement of skin capacitance, which indicates hydration level.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Volunteers aged 18-70 diagnosed with moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment.
Criteria

Inclusion Criteria:

  • Having 2 symetrical (left right)moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment

Exclusion Criteria:

  • Volunteers with a known allergy to one of the tested materials or to their ingredients.
  • Treatment with medication such as anti-inflammatories, anti-histamines, corticosteroids, systemically or topically applied, unless stopped for 4 weeks prior to the trial in the case of systemic treatment and 2 weeks in the case of topical treatment.
  • Volunteers in the process of diagnosis or treatment for cancer / kidney disease / liver disease
  • Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651559


Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Ahava Dead Sea Laboratories
Investigators
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Study Chair: Michael David, Professor Rabin Medical Center
More Information
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Responsible Party: Ahava Dead Sea Laboratories
ClinicalTrials.gov Identifier: NCT01651559    
Other Study ID Numbers: P7BH
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012
Keywords provided by Ahava Dead Sea Laboratories:
modified PASI
narrow band UVB phototherapy
Dead Sea Minerals
Skin auto-Fluorescence
Skin wash samples
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases