Trial record 7 of 119 for:    Open Studies | "Exanthema"

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. (see Contacts and Locations)
Verified August 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: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cetuximab-induced Papulopustular (Acneiform) Rash Who Have
Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
Drug: Topical Dapsone 5% Gel
Other: Moisturizer
Drug: oral antibiotics
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • difference in lesion counts [ Time Frame: 28 ± 2 days ] [ Designated as safety issue: No ]
    Lesion counts at day 28 ± 2 days (primary endpoint)


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Topical Dapsone 5% Gel Other: Moisturizer
The moisturizer for the study will be Vanicream™ Lite Lotion.
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)
Drug: Topical Dapsone 5% Gel Other: Moisturizer
The moisturizer for the study will be Vanicream™ Lite Lotion.
Drug: oral antibiotics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931150

Contacts
Contact: Mario Lacouture, MD 212-610-0079
Contact: Allan Halpern, MD 212-610-0766

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Mario Lacouture, MD    212-610-0079      
Contact: Allan Halpern, MD    212-610-0766      
Principal Investigator: Mario Lacouture, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Mario Lacouture, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01931150     History of Changes
Other Study ID Numbers: 13-012
Study First Received: August 26, 2013
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Topical Dapsone 5% Gel
Moisturizer
rash
13-012

Additional relevant MeSH terms:
Exanthema
Carcinoma
Carcinoma, Squamous Cell
Colorectal Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Skin Diseases
Anti-Bacterial Agents
Dapsone
Antibiotics, Antitubercular
Cetuximab
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 27, 2014