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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

This study has been completed.
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: November 18, 2016
Last verified: November 2016
Results First Received: January 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Cetuximab-induced Papulopustular (Acneiform) Rash Who Have
Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
Interventions: Drug: Topical Dapsone 5% Gel
Other: Moisturizer
Drug: oral antibiotics

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dapsone LEFT, Moisturizer RIGHT Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Dapsone RIGHT, Moisturizer LEFT Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.

Participant Flow:   Overall Study
    Dapsone LEFT, Moisturizer RIGHT   Dapsone RIGHT, Moisturizer LEFT
STARTED   5   6 
COMPLETED   4   4 
NOT COMPLETED   1   2 
Withdrawal by Subject                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dapsone LEFT, Moisturizer RIGHT Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Dapsone RIGHT, Moisturizer LEFT Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Total Total of all reporting groups

Baseline Measures
   Dapsone LEFT, Moisturizer RIGHT   Dapsone RIGHT, Moisturizer LEFT   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   6   11 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      5  83.3%      10  90.9% 
>=65 years      0   0.0%      1  16.7%      1   9.1% 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      2  33.3%      2  18.2% 
Male      5 100.0%      4  66.7%      9  81.8% 


  Outcome Measures

1.  Primary:   Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mario Lacouture
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-6014
e-mail: LacoutuM@mskcc.org



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
Results First Received: January 19, 2016
Last Updated: November 18, 2016