Cetuximab-induced Papulopustular (Acneiform) Rash Who Have, Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Topical Dapsone 5% Gel, Moisturizer, rash, 13-012
Brief 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. 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.
Interventions
DRUGTopical Dapsone 5% Gel
OTHERMoisturizer
The moisturizer for the study will be Vanicream™ Lite Lotion.
DRUGoral antibiotics
Sponsors
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions | 28 days | Change from Baseline in the Number of Lesions at 28 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapsone LEFT, Moisturizer RIGHT Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days. | 5 |
| Dapsone RIGHT, Moisturizer LEFT Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days. | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Dapsone LEFT, Moisturizer RIGHT | Dapsone RIGHT, Moisturizer LEFT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Gender Female | 0 Participants | 2 Participants | 2 Participants |
| Gender Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 1 / 6 |
Outcome results
Primary
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
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dapsone LEFT, Moisturizer RIGHT | Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions | 4 participants |
| Dapsone RIGHT, Moisturizer LEFT | Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions | 4 participants |