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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Ahava Dead Sea Laboratories.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651559
First Posted: July 27, 2012
Last Update Posted: November 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahava Dead Sea Laboratories
  Purpose
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
Psoriasis Vulgaris

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ahava Dead Sea Laboratories:

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


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Ahava Dead Sea Laboratories
Investigators
Study Chair: Michael David, Professor Rabin Medical Center
  More Information

Responsible Party: Ahava Dead Sea Laboratories
ClinicalTrials.gov Identifier: NCT01651559     History of Changes
Other Study ID Numbers: P7BH
First Submitted: July 10, 2012
First Posted: July 27, 2012
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:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases