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

July 10, 2012
November 14, 2012
November 2012
June 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01651559 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Volunteers aged 18-70 diagnosed with moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment.

Psoriasis Vulgaris
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01651559
P7BH
No
Ahava Dead Sea Laboratories
Ahava Dead Sea Laboratories
Not Provided
Study Chair: Michael David, Professor Rabin Medical Center
Ahava Dead Sea Laboratories
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP