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Cetuximab-induced Papulopustular (Acneiform) Rash Who Have | 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

Cetuximab-induced Papulopustular (Acneiform) Rash Who Have research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cetuximab-induced Papulopustular (Acneiform) Rash Who Have

Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Topical Dapsone 5% Gel

Other:MoisturizerThe moisturizer for the study will be Vanicream™ Lite Lotion.

Drug:oral antibiotics

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dapsone LEFT, Moisturizer RIGHTDapsone 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 LEFTMoisturizer 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)

Study Status

Completed

Start Date: August 2013

Completed Date: September 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mario Lacouture, MD

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Collaborator: Bristol-Myers Squibb

More information:https://clinicaltrials.gov/show/NCT01931150

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