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.
Information provided by (Responsible Party):
Ahava Dead Sea Laboratories
First received: July 10, 2012
Last updated: November 14, 2012
Last verified: November 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
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
- = Slight
- = 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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Volunteers aged 18-70 diagnosed with moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment.
- Having 2 symetrical (left right)moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01651559
|Hadassah Medical Center
|Jerusalem, Israel, 91120 |
|Rabin Medical Center
|Petah Tikva, Israel, 49100 |
Ahava Dead Sea Laboratories
||Michael David, Professor
||Rabin Medical Center
||Ahava Dead Sea Laboratories
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 10, 2012
||November 14, 2012
||Israel: Ministry of Health
Keywords provided by Ahava Dead Sea Laboratories:
ClinicalTrials.gov processed this record on April 27, 2016
narrow band UVB phototherapy
Dead Sea Minerals
Skin wash samples