Trial Outcomes & Findings for Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face (NCT NCT00489086)

NCT ID: NCT00489086

Last Updated: 2020-10-29

Results Overview

The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2020-10-29

Participant Flow

Participant milestones

Measure	Tazarotene Cream This is a 36 month, multi-center, single arm, open label clinical study design
Overall Study STARTED	36
Overall Study Completed 18 Months	23
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	23

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 Face

Baseline characteristics by cohort

Measure	Tazarotene Cream n=36 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.

Outcome measures

Measure	Tazarotene Cream n=34 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Complete Response Rate	2 Participants

SECONDARY outcome

Timeframe: 36 months

Population: N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

Outcome measures

Measure	Tazarotene Cream n=34 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Time to Lesion Clearance	NA Participants The PI has left the institution and the only access to the data is from the publication. The access to this specific data cannot be confirmed and is not available to be reported.

SECONDARY outcome

Timeframe: 36 months

Population: N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

Outcome measures

Measure	Tazarotene Cream n=34 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Time to Progression	NA Participants The PI has left the institution and the only access to the data is from the publication. The access to this specific data cannot be confirmed and is not available to be reported.

SECONDARY outcome

Timeframe: 36 months

Population: N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

Outcome measures

Measure	Tazarotene Cream n=34 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Estimated Duration of Complete Response	NA Participants The PI has left the institution and the only access to the data is from the publication. The access to this specific data cannot be confirmed and is not available to be reported.

SECONDARY outcome

Timeframe: 36 months

Population: N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene.

Outcome measures

Measure	Tazarotene Cream n=34 Participants This is a 36 month, multi-center, single arm, open label clinical study design
Overall Response at Treated Lesions	NA Participants The PI has left the institution and the only access to the data is from the publication. The access to this specific data cannot be confirmed and is not available to be reported.

Adverse Events

Tazarotene Cream

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tazarotene Cream n=36 participants at risk This is a 36 month, multi-center, single arm, open label clinical study design
Renal and urinary disorders prostate cancer diagnosis	2.8% 1/36 • 36 months
Ear and labyrinth disorders cellulitis and maxillary sinusitis	2.8% 1/36 • 36 months

Other adverse events

Measure	Tazarotene Cream n=36 participants at risk This is a 36 month, multi-center, single arm, open label clinical study design
Skin and subcutaneous tissue disorders irritation	16.7% 6/36 • 36 months
Skin and subcutaneous tissue disorders dryness	16.7% 6/36 • 36 months
Skin and subcutaneous tissue disorders inflammation	2.8% 1/36 • 36 months
Skin and subcutaneous tissue disorders itching	8.3% 3/36 • 36 months
Skin and subcutaneous tissue disorders peeling	11.1% 4/36 • 36 months
Skin and subcutaneous tissue disorders edema	2.8% 1/36 • 36 months
Skin and subcutaneous tissue disorders rash	11.1% 4/36 • 36 months
Skin and subcutaneous tissue disorders erythema	16.7% 6/36 • 36 months

Additional Information

Ervin H Epstein Jr., MD

Children's Hospital of Oakland Research Institute, Oakland

Phone: 510-450-5688

Email: eepstein@chori.org

Results disclosure agreements

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