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PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

Sponsor
Pharm Olam Pharmaceuticals Ltd. (Other)
Overall Status
Unknown status
CT.gov ID
NCT00840515
Collaborator
(none)
1
Enrollment
5.9
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Feb 1, 2009
    Anticipated Primary Completion Date :
    Jun 1, 2009
    Anticipated Study Completion Date :
    Aug 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Emulsion

    Outcome Measures

    Primary Outcome Measures

    1. Digital Camera [Weekly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pharm Olam Pharmaceuticals Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00840515
    Other Study ID Numbers:
    • SMC-5467
    • 20080772
    First Posted:
    Feb 10, 2009
    Last Update Posted:
    May 6, 2009
    Last Verified:
    May 1, 2009
    Additional relevant MeSH terms:
    Dermatitis
    Radiodermatitis

    Study Results

    No Results Posted as of May 6, 2009