Drug-Related Side Effects and Adverse ReactionsNCT03051880
Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
A study testing Cream without rhEGF in people with Drug-Related Side Effects and Adverse Reactions and Epidermal Growth Factor, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reactions, Epidermal Growth Factor
- What is being tested?
- Cream without rhEGF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Dec 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 years old
- Patients scheduled to receive EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors
- Patients who can understand and follow the protocol
- Patients who spontaneously agreed to the study
Who cannot join
- Patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders
- Patients with existing acne history
- Breastfeeding or pregnant women
- Patients who are deemed unsuitable for the examination by the researcher's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Jung Min Bae, MD, 82-31-249-8209, jminbae@gmail.com
About this study
Official title: The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.
Read the detailed description
Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.
The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.
There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.
There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.
The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).
- Being tested
- Repair Control EGF®, Cream without rhEGF
- Keywords
- Epidermal Growth Factor
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair Control EGF®Drug
Also called EGF cream containing 10 ppm of rhEGF
A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks.
EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)
Cream without rhEGFDrug
A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 weeks.
Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF
| Study group | Role | What they receive |
|---|---|---|
| Repair Control EGF® | Experimental | EGF cream was applied. One half side of face and one hand were treated with emollient containing EGF. Receives: Drug: Repair Control EGF® |
| Cream without rhEGF | Placebo comparator | Placebo cream without EGF was applied. The other half side of face and the other hand were treated with only emollient which was not containing EGF. Receives: Drug: Cream without rhEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of acneiform eruption caused by use of EGFR inhibitor
To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit.
If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS).
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcomes (6)
the change paronychia caused by use of EGFR inhibitor
The paronychia lesion will be assessed by CTCAE.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
the change of skin hydration
It measured with Corneometer® (CM820/825, C-K Electronics, Cologne, Germany). It shows in arbitrary units(AU) and the unit is from 0 to 220.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
the change of sebum production
It measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany). It is measured at forehead, cheek and chin, presented as /㎍ ㎠. It shows in arbitrary units(AU) and the unit is from 0 to 220.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Investigator's global assessment score
Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement).
Measured: Baseline, 8 weeks
Patient's global assessment score
Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement).
Measured: Baseline, 8 weeks
The side effects of product
It will be assessed by patient-report.
- Any event developed during the trials can be reported.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Related Side Effects and Adverse ReactionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Bae, The Catholic University of Korea
- Investigators
- Jung Min B, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051880
- Sponsor's protocol ID
- VC16EISE0180
- Status last verified
- Feb 2017
- First submitted
- 2 Dec 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
- ClinicalTrials.gov ID
- NCT03051880
- Acronym / sponsor ID
- VC16EISE0180
- Keywords
- Epidermal Growth Factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Feb 2017 (actual)
- 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 purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.
Detailed description
Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.
The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.
There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.
There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.
The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair Control EGF® | Experimental | Drug: Repair Control EGF®EGF cream was applied. One half side of face and one hand were treated with emollient containing EGF. |
| Cream without rhEGF | Placebo comparator | Drug: Cream without rhEGFPlacebo cream without EGF was applied. The other half side of face and the other hand were treated with only emollient which was not containing EGF. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 20 years old
- Patients scheduled to receive EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors
- Patients who can understand and follow the protocol
- Patients who spontaneously agreed to the study
Key exclusion criteria (4 listed)
- Patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders
- Patients with existing acne history
- Breastfeeding or pregnant women
- Patients who are deemed unsuitable for the examination by the researcher's judgment
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 |
|---|---|---|
| Repair Control EGF®Also: EGF cream containing 10 ppm of rhEGFA Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks. EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea) | Drug | Repair Control EGF® |
| Cream without rhEGFA Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 weeks. Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF | Drug | Cream without rhEGF |
Primary outcome
The change of acneiform eruption caused by use of EGFR inhibitor
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit. If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS).
6 secondary outcomes
the change paronychia caused by use of EGFR inhibitor
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
the change of skin hydration
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
the change of sebum production
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Investigator's global assessment score
Time frame: Baseline, 8 weeks
Patient's global assessment score
Time frame: Baseline, 8 weeks
The side effects of product
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jung Min B, MD, PhD study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cream without rhEGF in people with Drug-Related Side Effects and Adverse Reactions and Epidermal Growth Factor, run by The Catholic University of Korea at 1 site in South Korea.
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 4 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 14 Feb 2017. 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 South Korea. 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.
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 Jung Min Bae, MD, PhD (82-31-249-8209, jminbae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of acneiform eruption caused by use of EGFR inhibitor (time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 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 14 Feb 2017.