Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00489086
First received: June 20, 2007
Last updated: January 13, 2016
Last verified: January 2016
Results First Received: July 31, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplastic Syndrome
Intervention: Drug: tazarotene

  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
No text entered.

Reporting Groups
  Description
Tazarotene Cream This is a 36 month, multi-center, single arm, open label clinical study design

Participant Flow:   Overall Study
    Tazarotene Cream  
STARTED     36  
COMPLETED     13 [1]
NOT COMPLETED     23  
[1] 23 subjects completed 18 months



  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.
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Reporting Groups
  Description
Tazarotene Cream This is a 36 month, multi-center, single arm, open label clinical study design

Baseline Measures
    Tazarotene Cream  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  53  (10)  
Gender  
[units: participants]
 
Female     16  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   Complete Response Rate   [ Time Frame: 36 months ]

2.  Secondary:   Time to Lesion Clearance   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Progression   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Estimated Duration of Complete Response   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall Response at Treated Lesions   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
34 pts. were included in the analysis of the primary endpoint. 23 pts. completed 18 months (68%). Only 2 of 34 patients achieved complete resolution (CR = 5.9%). 13 pts. completed 36 month trial (first 18 months tazarotene, months 19-36 observation).


  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: Raj Prasad
Organization: ChildrensHRCOakland
phone: 510-450-7602 ext 7602
e-mail: rprasad@chori.org



Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT00489086     History of Changes
Obsolete Identifiers: NCT00500643
Other Study ID Numbers: CDR0000551655
R01CA109584 ( US NIH Grant/Contract Award Number )
P30CA082103 ( US NIH Grant/Contract Award Number )
Study First Received: June 20, 2007
Results First Received: July 31, 2013
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board