Cetuximab-induced Papulopustular (Acneiform) Rash Who HavePhase 3NCT01931150
Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT
A Phase 3 study testing Topical Dapsone 5% Gel, Moisturizer and oral antibiotics in people with Cetuximab-induced Papulopustular (Acneiform) Rash Who Have and Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cetuximab-induced Papulopustular (Acneiform) Rash Who Have, Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Topical Dapsone 5% Gel, Moisturizer and oral antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2015
- Phase
- Phase 3
- 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
- Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient
- Patients must provide written informed consent to participate in the study
- Anticipated initiation of cetuximab treatment with or without additional chemotherapy.
- Able to self-administer topical interventions or provide for another person to apply the topical interventions
Who cannot join
- Females of childbearing potential who are pregnant or nursing
- Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product
- Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion)
- Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days)
- Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)
- Previous therapy with cetuximab within 6 months of consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase III Randomized Double-blind Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT
The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.
- Conditions
- Cetuximab-induced Papulopustular (Acneiform) Rash Who Have, Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
- Being tested
- Topical Dapsone 5% Gel, Moisturizer, oral antibiotics
- Keywords
- Topical Dapsone 5% Gel, Moisturizer, rash, 13-012
- Medical subject headings
- Colorectal Neoplasms, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Dapsone 5% GelDrug
MoisturizerOther
The moisturizer for the study will be Vanicream™ Lite Lotion.
oral antibioticsDrug
| Study group | Role | What they receive |
|---|---|---|
| Dapsone LEFT, Moisturizer RIGHT | Experimental | Dapsone 5% gel to LEFT side of face and chest BID (morning and evening) Moisturizer to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily) Receives: Drug: Topical Dapsone 5% Gel; Other: Moisturizer; Drug: oral antibiotics |
| Dapsone RIGHT, Moisturizer LEFT | Experimental | Moisturizer to LEFT side of face and chest BID (morning and evening) Dapsone 5% gel to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily) Receives: Drug: Topical Dapsone 5% Gel; Other: Moisturizer; Drug: oral antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions
Change from Baseline in the Number of Lesions at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
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 Cetuximab-induced Papulopustular (Acneiform) Rash Who HaveStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Mario Lacouture, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931150
- Sponsor's protocol ID
- 13-012
- Status last verified
- Nov 2016
- First submitted
- 26 Aug 2013
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-blind Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT
- ClinicalTrials.gov ID
- NCT01931150
- Acronym / sponsor ID
- 13-012
- Conditions
- Cetuximab-induced Papulopustular (Acneiform) Rash Who Have, Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
- Keywords
- Topical Dapsone 5% Gel, Moisturizer, rash, 13-012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 13 Jan 2017
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 see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapsone LEFT, Moisturizer RIGHT | Experimental | Drug: Topical Dapsone 5% Gel, Other: Moisturizer, Drug: oral antibioticsDapsone 5% gel to LEFT side of face and chest BID (morning and evening) Moisturizer to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily) |
| Dapsone RIGHT, Moisturizer LEFT | Experimental | Drug: Topical Dapsone 5% Gel, Other: Moisturizer, Drug: oral antibioticsMoisturizer to LEFT side of face and chest BID (morning and evening) Dapsone 5% gel to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient
- Patients must provide written informed consent to participate in the study
- Anticipated initiation of cetuximab treatment with or without additional chemotherapy.
- Able to self-administer topical interventions or provide for another person to apply the topical interventions
Key exclusion criteria (6 listed)
- Females of childbearing potential who are pregnant or nursing
- Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product
- Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion)
- Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days)
- Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)
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 |
|---|---|---|
| Topical Dapsone 5% Gel | Drug | Dapsone LEFT, Moisturizer RIGHT, Dapsone RIGHT, Moisturizer LEFT |
| MoisturizerThe moisturizer for the study will be Vanicream™ Lite Lotion. | Other | Dapsone LEFT, Moisturizer RIGHT, Dapsone RIGHT, Moisturizer LEFT |
| oral antibiotics | Drug | Dapsone LEFT, Moisturizer RIGHT, Dapsone RIGHT, Moisturizer LEFT |
Primary outcome
Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions
Time frame: 28 days
Change from Baseline in the Number of Lesions at 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
Mario Lacouture, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Dapsone 5% Gel, Moisturizer and oral antibiotics in people with Cetuximab-induced Papulopustular (Acneiform) Rash Who Have and Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center 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?
The sponsor lists 4 inclusion and 6 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 13 Jan 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2017). 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?
Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions (time frame: 28 days). 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 13 Jan 2017.