Rash Due to Epidermal Growth Factor Receptor InhibitorsPhase 2EGFRINCT01763307
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI
A Phase 2 study testing RECONVAL CREAM in people with Rash Due to Epidermal Growth Factor Receptor Inhibitors, run by Hadassah Medical Organization.
Trial summary
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients. This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rash Due to Epidermal Growth Factor Receptor Inhibitors
- What is being tested?
- RECONVAL CREAM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- metastatic colon cancer patients
- male or female
- age> 18
- treated EGFRI
Who cannot join
- prior treatment with EGFRI
About this study
Official title: A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.
This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.
- Being tested
- RECONVAL CREAM, PLACEBO
- Keywords
- EGFRI, COLON CANCER, SKIN TOXICITY, RECONVAL K1 cream
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECONVAL CREAMDrug
PLACEBODrug
| Study group | Role | What they receive |
|---|---|---|
| RECONVAL CREAM | Experimental | half face treated with RECONVAL CREAM Receives: Drug: RECONVAL CREAM |
| PLACEBO | Placebo comparator | half face treated with PLACEBO cream Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rash Due to Epidermal Growth Factor Receptor InhibitorsStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Merims, MD, Principal investigator, Hadassah Medcial Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763307
- Sponsor's protocol ID
- EGFRI-MER-1a-HMO-CTIL
- Acronym
- EGFRI
- Status last verified
- Aug 2017
- First submitted
- 24 Dec 2012
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
- ClinicalTrials.gov ID
- NCT01763307
- Acronym / sponsor ID
- EGFRI / EGFRI-MER-1a-HMO-CTIL
- Keywords
- EGFRI, COLON CANCER, SKIN TOXICITY, RECONVAL K1 cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Jan 2013 (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.
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.
This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECONVAL CREAM | Experimental | Drug: RECONVAL CREAMhalf face treated with RECONVAL CREAM |
| PLACEBO | Placebo comparator | Drug: PLACEBOhalf face treated with PLACEBO cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- metastatic colon cancer patients
- male or female
- age> 18
- treated EGFRI
Key exclusion criteria (1 listed)
- prior treatment with EGFRI
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 |
|---|---|---|
| RECONVAL CREAM | Drug | RECONVAL CREAM |
| PLACEBO | Drug | PLACEBO |
Primary outcome
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
Time frame: 12 weeks
Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
Sharon Merims, MD principal investigator
Hadassah Medcial Organization
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RECONVAL CREAM in people with Rash Due to Epidermal Growth Factor Receptor Inhibitors, run by Hadassah Medical Organization.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 29 Feb 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI (time frame: 12 weeks). 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 29 Feb 2024.