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

NCT01931150 | Completed Phase 3 Results

• 1 other identifier: 13-012
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Topical Dapsone 5% Gel; Moisturizer; rash; 13-012

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Study Arms (2)

Dapsone LEFT, Moisturizer RIGHT

EXPERIMENTAL

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)

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

Dapsone RIGHT, Moisturizer LEFT

EXPERIMENTAL

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)

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

Interventions

Topical Dapsone 5% Gel DRUG

Dapsone LEFT, Moisturizer RIGHT; Dapsone RIGHT, Moisturizer LEFT

Moisturizer OTHER

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

Dapsone LEFT, Moisturizer RIGHT; Dapsone RIGHT, Moisturizer LEFT

oral antibiotics DRUG

Dapsone LEFT, Moisturizer RIGHT; Dapsone RIGHT, Moisturizer LEFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms; Exanthema

Interventions

Dapsone; Gels; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Mario Lacouture
• Organization: Memorial Sloan Kettering Cancer Center

LacoutuM@mskcc.org

646-888-6014

Study Officials

• Mario Lacouture, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 13, 2017
• Results First Posted: January 13, 2017

Record last verified: 2016-11

Locations

US (1)