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

This study is currently recruiting participants.
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01931150
First received: August 26, 2013
Last updated: February 26, 2014
Last verified: February 2014

August 26, 2013
February 26, 2014
August 2013
August 2015   (final data collection date for primary outcome measure)
difference in lesion counts [ Time Frame: 28 ± 2 days ] [ Designated as safety issue: No ]
Lesion counts at day 28 ± 2 days (primary endpoint)
difference in lesion counts [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
For each side of the face and chest, lesion counts will be completed in real-time by observers blinded to the treatment status. These real-time lesion counts will be used to assess the primary endpoint.
Complete list of historical versions of study NCT01931150 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cetuximab-induced Papulopustular (Acneiform) Rash Who Have
  • Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
  • Drug: Topical Dapsone 5% Gel
  • Other: Moisturizer
    The moisturizer for the study will be Vanicream™ Lite Lotion.
  • Drug: oral antibiotics
  • Experimental: Treatment Arm 1
    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)
    Interventions:
    • Drug: Topical Dapsone 5% Gel
    • Other: Moisturizer
    • Drug: oral antibiotics
  • Experimental: Treatment Arm 2
    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)
    Interventions:
    • Drug: Topical Dapsone 5% Gel
    • Other: Moisturizer
    • Drug: oral antibiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mario Lacouture, MD 212-610-0079
Contact: Allan Halpern, MD 212-610-0766
United States
 
NCT01931150
13-012
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Bristol-Myers Squibb
Principal Investigator: Mario Lacouture, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP