PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

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

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

Study Overview

• Status: Unknown
• Conditions: Prevention of Radiation Induced Dermatitis.

• Study Type: Observational
• Enrollment (Anticipated): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patientsplanned to receive whole breast radiation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Digital Camera	Weekly

Collaborators and Investigators

• Sponsor: Pharm Olam Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: February 7, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): May 6, 2009
• Last Update Submitted That Met QC Criteria: May 5, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: SMC-5467; 20080772