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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

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Topical Dapsone 5% Gel

Moisturizer

oral antibiotics

About this trial

This is an interventional treatment trial for Cetuximab-induced Papulopustular (Acneiform) Rash Who Have focused on measuring Topical Dapsone 5% Gel, Moisturizer, rash, 13-012

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dapsone LEFT, Moisturizer RIGHT

Dapsone RIGHT, Moisturizer LEFT

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01931150

First Posted

August 26, 2013

Last Updated

November 18, 2016

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01931150

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapsone LEFT, Moisturizer RIGHT

Arm Type

Experimental

Arm Description

Arm Title

Dapsone RIGHT, Moisturizer LEFT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Topical Dapsone 5% Gel

Intervention Type

Other

Intervention Name(s)

Moisturizer

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oral antibiotics

Primary Outcome Measure Information:

Title

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

Description

Change from Baseline in the Number of Lesions at 28 days

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Lacouture, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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