The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients
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.
|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|
- 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.
- 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.
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651559
|Hadassah Medical Center|
|Jerusalem, Israel, 91120|
|Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Study Chair:||Michael David, Professor||Rabin Medical Center|