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

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ClinicalTrials.gov Identifier: NCT00783965
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Carcinoma
Interventions Drug: tazarotene
Other: placebo
Enrollment 34

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm II
Hide Arm/Group Description 0.1% tazarotene cream first, then placebo Vehicle (placebo) first, then 0.1% tazarotene cream
Period Title: First Intervention (12 Months)
Started 5 29
Completed 2 25
Not Completed 3 4
Period Title: Second Intervention (24 Months)
Started 2 25
Completed 2 16
Not Completed 0 9
Arm/Group Title Arm I Arm II Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 5 29 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 29 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
29
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 29 participants 34 participants
54  (7) 51  (13) 53  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 29 participants 34 participants
Female
3
  60.0%
14
  48.3%
17
  50.0%
Male
2
  40.0%
15
  51.7%
17
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 29 participants 34 participants
5 29 34
1.Primary Outcome
Title Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter
Hide Description [Not Specified]
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5 29
Measure Type: Number
Unit of Measure: participants
5 29
2.Primary Outcome
Title Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0
Hide Description [Not Specified]
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5 29
Measure Type: Number
Unit of Measure: participants
5 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   2/29 (6.90%) 
Ear and labyrinth disorders     
cellulitis and maxillary sinusitis *  0/5 (0.00%)  1/29 (3.45%) 
Renal and urinary disorders     
prostate cancer diagnosis *  0/5 (0.00%)  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   26/29 (89.66%) 
Skin and subcutaneous tissue disorders     
Dryness   0/5 (0.00%)  6/29 (20.69%) 
Inflammation   1/5 (20.00%)  0/29 (0.00%) 
Itching   0/5 (0.00%)  3/29 (10.34%) 
Irritation   2/5 (40.00%)  4/29 (13.79%) 
Peeling   0/5 (0.00%)  4/29 (13.79%) 
Edema   0/5 (0.00%)  1/29 (3.45%) 
Rash   0/5 (0.00%)  4/29 (13.79%) 
Erythema   2/5 (40.00%)  4/29 (13.79%) 
Indicates events were collected by systematic assessment
Non-compliance and large drop-out rates leading to small numbers of data analyzed.
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
Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT00783965     History of Changes
Other Study ID Numbers: CDR0000618240
5R01CA109584-05 ( U.S. NIH Grant/Contract )
U19CA081888 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: July 31, 2013
Results First Posted: February 11, 2016
Last Update Posted: February 11, 2016