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

Ahava Dead Sea Laboratories50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Psoriasis Vulgaris

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Outcomes

Primary Outcomes

change from baseline of PASI (Psoriasis Area and Severity Index)

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.

Time frame: 8 weeks

Secondary Outcomes

change from baseline of the Skin Hydration level

corneometric measurement of skin capacitance, which indicates hydration level.

Time frame: 8 weeks