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

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:
NCT00783965
First received: October 31, 2008
Last updated: January 13, 2016
Last verified: January 2016
Results First Received: July 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Skin Carcinoma
Interventions: Drug: tazarotene
Other: placebo

  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
Arm I 0.1% tazarotene cream first, then placebo
Arm II Vehicle (placebo) first, then 0.1% tazarotene cream

Participant Flow for 2 periods

Period 1:   First Intervention (12 Months)
    Arm I   Arm II
STARTED   5   29 
COMPLETED   2   25 
NOT COMPLETED   3   4 

Period 2:   Second Intervention (24 Months)
    Arm I   Arm II
STARTED   2   25 
COMPLETED   2   16 
NOT COMPLETED   0   9 



  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
Arm I

Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.

placebo : Applied to the skin

tazarotene : Applied to the skin

Arm II

Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.

placebo : Applied to the skin

tazarotene : Applied to the skin

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   29   34 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   5   29   34 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (7)   51  (13)   53  (10) 
Gender 
[Units: Participants]
     
Female   3   14   17 
Male   2   15   17 
Region of Enrollment 
[Units: Participants]
     
United States   5   29   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter   [ Time Frame: Baseline and 36 months ]

2.  Primary:   Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0   [ Time Frame: Baseline and 36 months ]


  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
Non-compliance and large drop-out rates leading to small numbers of data analyzed.


  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: NCT00783965     History of Changes
Other Study ID Numbers: CDR0000618240
5R01CA109584-05 ( US NIH Grant/Contract Award Number )
U19CA081888 ( US NIH Grant/Contract Award Number )
Study First Received: October 31, 2008
Results First Received: July 31, 2013
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board