Atopic DermatitisNCT01307150
Climatotherapy At The Dead Sea For Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atopic Dermatitis patient.
Who may be able to join
- Minimum age of 18 years old
Who cannot join
- Skin type - I
- Psoriasis patient in addition to Atopic Dermatitis
- Pregnancy
- Past malignancy
- Less then 2 weeks of treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site
DMZ Clinic
Jerusalem
Marco Harari, Dr., +972-(0)8-6689200, Doctor@LotHotel.co.il
About this study
Official title: Evaluation of the Efficacy of Dead Sea Climatotherapy on Atopic Dermatitis Patients.
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Dead Sea, Climatotherapy, SCORAD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before and after treatment | SCORAD of each patient before and after treatment. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Arie Ingber, MD., Study chair, Hadassa Medical Organization IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307150
- Sponsor's protocol ID
- SK09409-HMO-CTIL
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10651969
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Dead Sea Climatotherapy on Atopic Dermatitis Patients.
- ClinicalTrials.gov ID
- NCT01307150
- Acronym / sponsor ID
- SK09409-HMO-CTIL
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Dead Sea, Climatotherapy, SCORAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before and after treatment | – | –SCORAD of each patient before and after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atopic Dermatitis patient.
Key inclusion criteria (1 listed)
- Minimum age of 18 years old
Key exclusion criteria (5 listed)
- Skin type - I
- Psoriasis patient in addition to Atopic Dermatitis
- Pregnancy
- Past malignancy
- Less then 2 weeks of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
- Results publication: PubMed 10651969Harari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Ingber, MD. study chair
Hadassa Medical Organization IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzukert, DMD (+972-(0)2-6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.