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

Phase 3

Completed

• Conditions: Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma; Cetuximab-induced Papulopustular (Acneiform) Rash Who Have
• Interventions: Drug: Topical Dapsone 5% Gel; Other: Moisturizer; Drug: oral antibiotics

• Registration Number: NCT01931150
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-29
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-01-19
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-18
• Last Update Submitted: 2016-11-18
• Results First Posted: 2017-01-13
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapsone LEFT, Moisturizer RIGHT	Topical Dapsone 5% Gel	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)
Dapsone LEFT, Moisturizer RIGHT	Moisturizer	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)
Dapsone RIGHT, Moisturizer LEFT	Topical Dapsone 5% Gel	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)
Dapsone LEFT, Moisturizer RIGHT	oral antibiotics	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)
Dapsone RIGHT, Moisturizer LEFT	Moisturizer	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)
Dapsone RIGHT, Moisturizer LEFT	oral antibiotics	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States