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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01651559

Enrollment

Registered

2012-07-27

Start date

2012-11-30

Completion date

2013-06-30

Last updated

2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Keywords

modified PASI, narrow band UVB phototherapy, Dead Sea Minerals, Skin auto-Fluorescence, Skin wash samples

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Israel

Outcome results