Dermatologic ComplicationsNCT01393821
Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
A study testing menadione topical lotion, questionnaire administration and management of therapy complications in people with Dermatologic Complications and Malignant Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial summary
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Complications, Malignant Neoplasm, Pain
- What is being tested?
- menadione topical lotion, questionnaire administration and management of therapy complications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2012to 14 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older.
- Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
- Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
- Willing to have photographs taken to assess rash.
Who cannot join
- Any active facial and/or chest rash, including adult acne, at the time of randomization.
- Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
- Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
- Any type of ongoing therapy for rash.
- Any of the following:
- Pregnant women
Show all 9Show fewer
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Campus in Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
Read the detailed description
PRIMARY OBJECTIVES:
- Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.
SECONDARY OBJECTIVES:
- Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.
II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.
ARM II: Patients apply topical placebo lotion BID for 28 days.
After completion of study treatment, patients are followed up for 4 weeks.
- Conditions
- Dermatologic Complications, Malignant Neoplasm, Pain
- Being tested
- menadione topical lotion, placebo, questionnaire administration, management of therapy complications
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menadione topical lotionDrug
Given topically
placeboOther
Also called PLCB
Given topically
questionnaire administrationOther
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Given menadione topical lotion
| Study group | Role | What they receive |
|---|---|---|
| Arm I (lotion) | Experimental | Patients apply menadione topical lotion BID for 28 days. Receives: Drug: menadione topical lotion; Other: questionnaire administration; Procedure: management of therapy complications |
| Arm II (placebo) | Placebo comparator | Patients apply topical placebo lotion BID for 28 days. Receives: Other: placebo; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.
Measured: From Baseline to Week 4
Secondary outcomes (3)
The Number of Patients Experiencing Worst Toxicity
The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.
Measured: Up to 8 weeks
Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)
Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.
Measured: Baseline, 4 weeks
Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)
Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study start23 Jan 2012
- Primary completion11 May 2013
- Study completion14 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatologic ComplicationsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393821
- Sponsor's protocol ID
- MC10C9
- Other IDs
- NCI-2011-01047, 11-001566, R21CA134432
- Status last verified
- May 2025
- First submitted
- 27 Jun 2011
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
- ClinicalTrials.gov ID
- NCT01393821
- Acronym / sponsor ID
- MC10C9
- Conditions
- Dermatologic Complications, Malignant Neoplasm, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jan 2012 (actual)
- Primary completion
- 11 May 2013 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 16 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
Detailed description
PRIMARY OBJECTIVES:
- Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.
SECONDARY OBJECTIVES:
- Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.
II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.
ARM II: Patients apply topical placebo lotion BID for 28 days.
After completion of study treatment, patients are followed up for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (lotion) | Experimental | Drug: menadione topical lotion, Other: questionnaire administration, Procedure: management of therapy complicationsPatients apply menadione topical lotion BID for 28 days. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: questionnaire administrationPatients apply topical placebo lotion BID for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
- Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
Key exclusion criteria (9 listed)
- Any active facial and/or chest rash, including adult acne, at the time of randomization.
- Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
- Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
- Any type of ongoing therapy for rash.
- Any of the following:
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 |
|---|---|---|
| menadione topical lotionGiven topically | Drug | Arm I (lotion) |
| placeboAlso: PLCBGiven topically | Other | Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (lotion), Arm II (placebo) |
| management of therapy complicationsAlso: complications of therapy, management ofGiven menadione topical lotion | Procedure or surgery | Arm I (lotion) |
Primary outcome
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
Time frame: From Baseline to Week 4
Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.
3 secondary outcomes
The Number of Patients Experiencing Worst Toxicity
Time frame: Up to 8 weeks
Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)
Time frame: Baseline, 4 weeks
Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink 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.
Aminah Jatoi, M.D. study chair
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing menadione topical lotion, questionnaire administration and management of therapy complications in people with Dermatologic Complications and Malignant Neoplasm, run by Mayo Clinic at 2 sites 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?
The sponsor lists 6 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: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort (time frame: From Baseline to Week 4). 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 16 May 2025.