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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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Topical Dapsone 5% Gel (Drug); Moisturizer (Other); oral antibiotics (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Mario Lacouture, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Mario Lacouture, MD, Phone: 212-610-0079

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: difference in lesion counts

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mario Lacouture, MD, Phone: 212-610-0079

Memorial Sloan Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Mario Lacouture, MD, Phone: 212-610-0079
Allan Halpern, MD, Phone: 212-610-0766
Mario Lacouture, MD, Principal Investigator
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: August 2013
Last updated: March 2, 2015

Page last updated: August 20, 2015

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