PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Pharm Olam Pharmaceuticals Ltd..
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Pharm Olam Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT00840515

First received: February 7, 2009

Last updated: May 5, 2009

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 7, 2009
Last Updated Date	May 5, 2009
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2009)	Digital Camera [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00840515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis
Official Title ^ICMJE	A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
Brief Summary	A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Female patientsplanned to receive whole breast radiation.
Condition ^ICMJE	Prevention of Radiation Induced Dermatitis.
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Emulsion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	1
Estimated Completion Date	August 2009
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy. Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed. ECOG PERFORMANCE STATUS 0-1. Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control. No co-morbidities known to affect radiotherapy reactions. No co-existing acute or chronic skin disease. No evidence of infection or inflammation of breast to be treated. Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study. Exclusion Criteria: Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation. Prior radiotherapy to any site. Collagen vascular disease. Diabetes mellitus requiring medication. Uncontrolled hypertension. Participation in other clinical study. Any contra-indicating to treatment with Melatonin. History of allergy to peanuts or fragrances. History of severe allergic reactions (e.g. asthma).
Gender	Female
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00840515
Other Study ID Numbers ^ICMJE	SMC-5467, 20080772
Has Data Monitoring Committee	No
Responsible Party	Roni Eilon, Pharm Olam Pharmaceutics Ltd.
Study Sponsor ^ICMJE	Pharm Olam Pharmaceuticals Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pharm Olam Pharmaceuticals Ltd.
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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