Radiation DermatitisPhase 2kam1403NCT02051907
Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis
A Phase 2 study testing KAM1403 Gel and aloevera gel in people with Radiation Dermatitis, run by Kamedis Ltd. at 1 site in Israel.
Trial summary
The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- KAM1403 Gel and aloevera gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female above 18 years of age
- Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
- Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
- Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
- Minimum of 3 weeks from chemotherapy to start of radiation therapy.
- Patient agrees to use only the test products during the study period
Who cannot join
- Tumor involvement of the skin
- Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
- Patient has a previous history of allergy to the ingredients of the tested formulations
- Paget's disease of the nipple.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sourasky Medical Center
Tel Aviv
Diana Matchiavsky, MD, 972 3 697 4815, dianam@tlvmc.gov.il
Diana Matchiavsky, MD
About this study
Official title: A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS
The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.
- Conditions
- Radiation Dermatitis
- Being tested
- KAM1403 Gel, aloevera gel
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAM1403 GelDevice
aloevera gelDevice
| Study group | Role | What they receive |
|---|---|---|
| KAM1403 Gel | Experimental | A group treated with KAM1403 for the study period. Receives: Device: KAM1403 Gel |
| Aloevera Gel | Sham comparator | A group treated with Aloevera Gel for the study period Receives: Device: aloevera gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Radiation dermatitis symptoms
Changes in Radiation dermatitis symptoms assessment during and post radiotherapy (erythema, desquamation, edema, moist desquamation and ulceration) using the Radiation Therapy Oncology Group toxicity scoring system in the treatment group versus the control group
Measured: Day 0, weeks 2, 4, 6.5, 8.5
Secondary outcomes (2)
Subjects' self evaluation
Measured: Day 0, weeks 2, 4, 6.5, 8.5
Number of Adverse Events
Measured: Day 0, weeks 2, 4, 6.5, 8.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamedis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Matchiavsky, MD, Principal investigator, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051907
- Sponsor's protocol ID
- KAM-RAD-01
- Acronym
- kam1403
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS
- ClinicalTrials.gov ID
- NCT02051907
- Acronym / sponsor ID
- kam1403 / KAM-RAD-01
- Conditions
- Radiation Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kamedis Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 31 Jan 2014 (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.
The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAM1403 Gel | Experimental | Device: KAM1403 GelA group treated with KAM1403 for the study period. |
| Aloevera Gel | Sham comparator | Device: aloevera gelA group treated with Aloevera Gel for the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female above 18 years of age
- Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
- Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
- Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
- Minimum of 3 weeks from chemotherapy to start of radiation therapy.
Key exclusion criteria (5 listed)
- Tumor involvement of the skin
- Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
- Patient has a previous history of allergy to the ingredients of the tested formulations
- Paget's disease of the nipple.
- Pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAM1403 Gel | Device | KAM1403 Gel |
| aloevera gel | Device | Aloevera Gel |
Primary outcome
Changes in Radiation dermatitis symptoms
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Changes in Radiation dermatitis symptoms assessment during and post radiotherapy (erythema, desquamation, edema, moist desquamation and ulceration) using the Radiation Therapy Oncology Group toxicity scoring system in the treatment group versus the control group
2 secondary outcomes
Subjects' self evaluation
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Number of Adverse Events
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Sponsor's siteLink provided by the sponsor.
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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.
Diana Matchiavsky, MD principal investigator
Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAM1403 Gel and aloevera gel in people with Radiation Dermatitis, run by Kamedis Ltd. at 1 site in Israel.
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 6 inclusion and 5 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 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Helena Gryner, M.Sc. (+972 73 7969040, Helena@Kamedis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Radiation dermatitis symptoms (time frame: Day 0, weeks 2, 4, 6.5, 8.5). 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 31 Jan 2014.