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
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
|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 May 26, 2016
narrow band UVB phototherapy
Dead Sea Minerals
Skin wash samples