Climatotherapy At The Dead Sea For Atopic Dermatitis | NCT01307150

Studies
Climatotherapy At The Dead Sea For Atopic Dermatitis

NCT01307150

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 2, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Nov 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2011

Last Update Posted Date

Mar 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis and quality of life after 4 weeks of treatment in the Dead Sea.

Detailed Description

28 days treatment period, sun exposure and possibly Dead Sea baths after an exact given plan, discontinuation of all local Cortisone preparations, unlimited use of maintenance drags, doctor visit twice a week, continuous checks by the nurse.

Determination of the SCORAD index by the same doctor on arrival and departure. Before and after the treatment, the patient will answer written questionnaires regarding quality of life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before and after treatment		SCORAD of each patient before and after treatment.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minimum age of 18 years old

Exclusion Criteria:

Skin type - I
Psoriasis patient in addition to Atopic Dermatitis
Pregnancy
Past malignancy
Less then 2 weeks of treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Atopic Dermatitis patient.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arik Tzukert, DMD	Contact	+972-(0)2-6776095		arik@hadassah.org.il
Hadas Lemberg, PhD	Contact	+972-(0)2-6777572		1hadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Arie Ingber, MD.	Hadassa Medical Organization IRB	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DMZ Clinic		Jerusalem			Israel	Marco Harari, Dr.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10651969	Result	Harari M, Shani J, Seidl V, Hristakieva E. Climatotherapy of atopic dermatitis at the Dead Sea: demographic evaluation and cost-effectiveness. Int J Dermatol. 2000 Jan;39(1):59-69. doi: 10.1046/j.1365-4362.2000.00840.x.

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis