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

NCT ID: NCT01931150

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-09-30

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.

Conditions

Cetuximab-induced Papulopustular (Acneiform) Rash Who Have; Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dapsone LEFT, Moisturizer RIGHT

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)

Group Type: EXPERIMENTAL

Topical Dapsone 5% Gel

Intervention Type: DRUG

Moisturizer

Intervention Type: OTHER

The moisturizer for the study will be Vanicream™ Lite Lotion.

oral antibiotics

Intervention Type: DRUG

Dapsone RIGHT, Moisturizer LEFT

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)

Group Type: EXPERIMENTAL

Topical Dapsone 5% Gel

Intervention Type: DRUG

Moisturizer

Intervention Type: OTHER

The moisturizer for the study will be Vanicream™ Lite Lotion.

oral antibiotics

Intervention Type: DRUG

Interventions

Topical Dapsone 5% Gel

Intervention Type: DRUG

Moisturizer

The moisturizer for the study will be Vanicream™ Lite Lotion.

Intervention Type: OTHER

oral antibiotics

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Lacouture, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

13-012

Identifier Type: -

Identifier Source: org_study_id