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PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Pharm Olam Pharmaceuticals Ltd.

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

Condition or disease
Prevention of Radiation Induced Dermatitis.

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
Study Start Date : February 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : August 2009

Group/Cohort
Emulsion



Primary Outcome Measures :
  1. Digital Camera [ Time Frame: Weekly ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patientsplanned to receive whole breast radiation.
Criteria

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).

Responsible Party: Roni Eilon, Pharm Olam Pharmaceutics Ltd.
ClinicalTrials.gov Identifier: NCT00840515     History of Changes
Other Study ID Numbers: SMC-5467
20080772
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: May 6, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries