This trial is active, not recruiting.

Condition prevention of radiation induced dermatitis.
Phase phase 2
Sponsor Pharm Olam Pharmaceuticals Ltd.
Start date February 2009
End date June 2009
Trial size 1 participant
Trial identifier NCT00840515, 20080772, SMC-5467


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Digital Camera
time frame: Weekly

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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).

Additional Information

Official title A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Pharm Olam Pharmaceuticals Ltd..