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

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT01651559
• Lead Sponsor: Ahava Dead Sea Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-27
• Status Verified: 2012-11
• Study Start: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-15
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from baseline of PASI (Psoriasis Area and Severity Index)	8 weeks	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

Name	Time	Method
change from baseline of the Skin Hydration level	8 weeks	corneometric measurement of skin capacitance, which indicates hydration level.

Trial Locations

Locations (2)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel