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
  Purpose

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


Condition Phase
Prevention of Radiation Induced Dermatitis.
Phase 2

Study Type: Observational
Study Design: 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.

Further study details as provided by Pharm Olam Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Digital Camera [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: February 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Roni Eilon, Pharm Olam Pharmaceutics Ltd.
ClinicalTrials.gov Identifier: NCT00840515     History of Changes
Other Study ID Numbers: SMC-5467, 20080772
Study First Received: February 7, 2009
Last Updated: May 5, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on July 23, 2014