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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ahava Dead Sea Laboratories
ClinicalTrials.gov Identifier:
NCT01651559
First received: July 10, 2012
Last updated: November 14, 2012
Last verified: November 2012
  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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ahava Dead Sea Laboratories
ClinicalTrials.gov Identifier: NCT01651559     History of Changes
Other Study ID Numbers: P7BH
Study First Received: July 10, 2012
Last Updated: November 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Ahava Dead Sea Laboratories:
modified PASI
narrow band UVB phototherapy
Dead Sea Minerals
Skin auto-Fluorescence
Skin wash samples

ClinicalTrials.gov processed this record on September 30, 2014