Trial Outcomes & Findings for Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back (NCT NCT00783965)

NCT ID: NCT00783965

Last Updated: 2016-02-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline and 36 months
• Results posted on: 2016-02-11

Participant Flow

Participant milestones

Measure	Arm I 0.1% tazarotene cream first, then placebo	Arm II Vehicle (placebo) first, then 0.1% tazarotene cream
First Intervention (12 Months) STARTED	5	29
First Intervention (12 Months) COMPLETED	2	25
First Intervention (12 Months) NOT COMPLETED	3	4
Second Intervention (24 Months) STARTED	2	25
Second Intervention (24 Months) COMPLETED	2	16
Second Intervention (24 Months) NOT COMPLETED	0	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm I n=5 Participants 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 n=29 Participants 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 n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	29 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 7 • n=5 Participants	51 years STANDARD_DEVIATION 13 • n=7 Participants	53 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	29 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 36 months

Outcome measures

Measure	Arm I n=5 Participants 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 n=29 Participants 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
Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter	5 participants	29 participants

PRIMARY outcome

Timeframe: Baseline and 36 months

Outcome measures

Measure	Arm I n=5 Participants 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 n=29 Participants 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
Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0	5 participants	29 participants

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm II

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=5 participants at risk 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 n=29 participants at risk 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
Renal and urinary disorders prostate cancer diagnosis	0.00% 0/5	3.4% 1/29
Ear and labyrinth disorders cellulitis and maxillary sinusitis	0.00% 0/5	3.4% 1/29

Other adverse events

Measure	Arm I n=5 participants at risk 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 n=29 participants at risk 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
Skin and subcutaneous tissue disorders Dryness	0.00% 0/5	20.7% 6/29
Skin and subcutaneous tissue disorders Inflammation	20.0% 1/5	0.00% 0/29
Skin and subcutaneous tissue disorders Itching	0.00% 0/5	10.3% 3/29
Skin and subcutaneous tissue disorders Irritation	40.0% 2/5	13.8% 4/29
Skin and subcutaneous tissue disorders Peeling	0.00% 0/5	13.8% 4/29
Skin and subcutaneous tissue disorders Edema	0.00% 0/5	3.4% 1/29
Skin and subcutaneous tissue disorders Rash	0.00% 0/5	13.8% 4/29
Skin and subcutaneous tissue disorders Erythema	40.0% 2/5	13.8% 4/29

Additional Information

Raj Prasad

ChildrensHRCOakland

Phone: 510-450-7602

Email: rprasad@chori.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place