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PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840515
Recruitment Status : Unknown
Verified May 2009 by Pharm Olam Pharmaceuticals Ltd..
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2009
Last Update Posted : May 6, 2009
Information provided by:
Pharm Olam Pharmaceuticals Ltd.

February 7, 2009
February 10, 2009
May 6, 2009
February 2009
June 2009   (Final data collection date for primary outcome measure)
Digital Camera [ Time Frame: Weekly ]
Same as current
Complete list of historical versions of study NCT00840515 on 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 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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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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.
  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).
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Roni Eilon, Pharm Olam Pharmaceutics Ltd.
Pharm Olam Pharmaceuticals Ltd.
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Pharm Olam Pharmaceuticals Ltd.
May 2009