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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01651559
• Other study ID #: P7BH
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 10, 2012
• Last updated: November 14, 2012
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Ahava Dead Sea Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis Vulgaris

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Ahava Dead Sea Laboratories

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; = 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.	8 weeks	No
Secondary	change from baseline of the Skin Hydration level	corneometric measurement of skin capacitance, which indicates hydration level.	8 weeks	No