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
Recruitment status was Active, not recruiting
Sponsor:
Pharm Olam Pharmaceuticals Ltd.
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
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Purpose
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.
| 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) |
| Groups/Cohorts |
|---|
| Emulsion |
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:
- Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
- Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
- ECOG PERFORMANCE STATUS 0-1.
- Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
- No co-morbidities known to affect radiotherapy reactions.
- No co-existing acute or chronic skin disease.
- No evidence of infection or inflammation of breast to be treated.
- Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.
Exclusion Criteria:
- Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
- Prior radiotherapy to any site.
- Collagen vascular disease.
- Diabetes mellitus requiring medication.
- Uncontrolled hypertension.
- Participation in other clinical study.
- Any contra-indicating to treatment with Melatonin.
- History of allergy to peanuts or fragrances.
- History of severe allergic reactions (e.g. asthma).
Contacts and Locations
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 June 18, 2013