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NCT00840515 Clinical Trial

PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

Prevention of Radiation Induced Dermatitis. Clinical Trial

Official title:
A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00840515
Other study ID # SMC-5467
Secondary ID 20080772
Status Active, not recruiting
Phase Phase 2
First received February 7, 2009
Last updated May 5, 2009
Start date February 2009
Est. completion date August 2009

Study information
Verified date May 2009
Source Pharm Olam Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pharm Olam Pharmaceuticals Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Digital Camera Weekly No