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

February 7, 2009
May 5, 2009
February 2009
June 2009   (final data collection date for primary outcome measure)
Digital Camera [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00840515 on ClinicalTrials.gov Archive Site
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PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis
A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.

A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Female patientsplanned to receive whole breast radiation.

Prevention of Radiation Induced Dermatitis.
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Emulsion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1
August 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
  2. Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
  3. ECOG PERFORMANCE STATUS 0-1.
  4. Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
  5. No co-morbidities known to affect radiotherapy reactions.
  6. No co-existing acute or chronic skin disease.
  7. No evidence of infection or inflammation of breast to be treated.
  8. Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

Exclusion Criteria:

  1. Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
  2. Prior radiotherapy to any site.
  3. Collagen vascular disease.
  4. Diabetes mellitus requiring medication.
  5. Uncontrolled hypertension.
  6. Participation in other clinical study.
  7. Any contra-indicating to treatment with Melatonin.
  8. History of allergy to peanuts or fragrances.
  9. History of severe allergic reactions (e.g. asthma).
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00840515
SMC-5467, 20080772
No
Roni Eilon, Pharm Olam Pharmaceutics Ltd.
Pharm Olam Pharmaceuticals Ltd.
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Pharm Olam Pharmaceuticals Ltd.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP