Dermatologic ComplicationsNCT00498992
Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
A study testing collagen/aloe vera/vitamin E/lidocaine topical hydrogel in people with Dermatologic Complications and Unspecified Adult Solid Tumor, Protocol Specific, run by Ingalls Memorial Hospital at 1 site in United States.
Trial summary
RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- collagen/aloe vera/vitamin E/lidocaine topical hydrogel
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to not given
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel
- No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent topical facial creams or lotions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Clinical Trials Office - Ingalls Cancer Care Center at Ingalls, 708-915-4673
About this study
Official title: Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.
PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.
Secondary
- Determine the efficacy of this drug in reducing the severity of rash in these patients.
- Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.
- Determine the tolerability of this drug in these patients.
OUTLINE: This is a prospective study.
- Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.
- Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.
Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.
- Being tested
- collagen/aloe vera/vitamin E/lidocaine topical hydrogel
- Keywords
- dermatologic complications, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen/aloe vera/vitamin E/lidocaine topical hydrogelDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
Secondary outcomes (2)
Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic ComplicationsStudies 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 N/A
- Primary purpose
- Supportive care
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingalls Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mark F. Kozloff, MD, Study chair, Ingalls Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498992
- Sponsor's protocol ID
- CDR0000553120
- Other IDs
- IMH-REG-ING-100, MPMM-IMH-REG-ING-100
- Status last verified
- Jul 2009
- First submitted
- 10 Jul 2007
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
- ClinicalTrials.gov ID
- NCT00498992
- Acronym / sponsor ID
- CDR0000553120
- Keywords
- dermatologic complications, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ingalls Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 11 Jul 2007 (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.
RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.
PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.
Secondary
- Determine the efficacy of this drug in reducing the severity of rash in these patients.
- Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.
- Determine the tolerability of this drug in these patients.
OUTLINE: This is a prospective study.
- Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.
- Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.
Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| collagen/aloe vera/vitamin E/lidocaine topical hydrogel | Dietary supplement | – |
Primary outcome
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
2 secondary outcomes
Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Mark F. Kozloff, MD study chair
Ingalls Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen/aloe vera/vitamin E/lidocaine topical hydrogel in people with Dermatologic Complications and Unspecified Adult Solid Tumor, Protocol Specific, run by Ingalls Memorial Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Sep 2013. 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 United States. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching. 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 20 Sep 2013.