Prevention of Radiation Induced Dermatitis.NCT00840515
PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis
An observational study of Prevention of Radiation Induced Dermatitis., run by Pharm Olam Pharmaceuticals Ltd..
Trial summary
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Prevention of Radiation Induced Dermatitis.
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patientsplanned to receive whole breast radiation.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Any contra-indicating to treatment with Melatonin.
- History of allergy to peanuts or fragrances.
- History of severe allergic reactions (e.g. asthma).
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emulsion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Camera
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Radiation Induced Dermatitis.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharm Olam Pharmaceuticals Ltd.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840515
- Sponsor's protocol ID
- SMC-5467
- Other IDs
- 20080772
- Status last verified
- May 2009
- First submitted
- 7 Feb 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
- ClinicalTrials.gov ID
- NCT00840515
- Acronym / sponsor ID
- SMC-5467
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Pharm Olam Pharmaceuticals Ltd.University, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emulsion | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patientsplanned to receive whole breast radiation.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital Camera
Time frame: Weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Radiation Induced Dermatitis., run by Pharm Olam Pharmaceuticals Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Camera (time frame: Weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2009.