Trial Outcomes & Findings for Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions (NCT NCT04071756)

Last Updated: 2024-02-07

Results Overview

Grade 2 or higher hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop grade-2 or higher HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2024-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Topical Tazarotene 0.1% Gel Plus BPS * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Overall Study STARTED	5	3
Overall Study Patient Reported Outcomes (PRO) Evaluable	2	1
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=5 Participants * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS n=3 Participants * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs	Total n=8 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 11.1 • n=5 Participants	44.0 years STANDARD_DEVIATION 18.0 • n=7 Participants	55.0 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Body Mass Index (BMI)	23.3 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 7.1 • n=7 Participants	26 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Outcome measures
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=5 Participants * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS n=3 Participants * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate	20 percent of participants	33.33 percent of participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Any grade hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.

Outcome measures

Outcome measures
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=5 Participants * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS n=3 Participants * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
All Grade Hand-Foot Skin Reaction (HFSR) Rate	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: At baseline and at day 56.

Population: Trial was terminated at enrollment of 8 participants including n=3 on the placebo arm; the PRO evaluable sample for the placebo arm is not provided due to patient privacy.

HFS-14 is a specific quality of life scale developed for patients suffering from Hand-Foot Syndrome. It involves 14 questions per protocol Appendix D. Answers are ranked based on the subscripts listed from the level that affect quality of life much to less. Answers are ranked based on the subscripts from survey to not affect life quality (1-4). Maximum score is 44, and minimum score is 14. Change measured from baseline and day 56. Higher score means worse situation.

Outcome measures

Outcome measures
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=2 Participants * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Change in HFS-14 Score From Baseline to Day 56	1 units on a scale Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: at baseline and day 56

Population: Trial was terminated at enrollment of 8 participants including n=3 on the placebo arm; the PRO evaluable sample for the placebo arm is not provided due to patient privacy.

PSS is a classic stress assessment instrument that helping understand how different situations affect patients' feelings and perceived stress. Patients answer 10 questions defined in protocol appendix D. Answers are ranked 0-4. The higher the overall scores indicate higher perceived stress. Score range is from 0 to 40. Higher score means more stressful. Change measured at baseline and day 56.

Outcome measures

Outcome measures
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=2 Participants * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Change in Perceived Stress Scale (PSS) From Baseline to Day 56	7.5 units on a scale Interval 0.0 to 13.0	—

Adverse Events

Topical Tazarotene 0.1% Gel Plus BPS

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Gel Plus BPS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=5 participants at risk * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS n=3 participants at risk * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Gastrointestinal disorders Biliary stent blockage	20.0% 1/5 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	0.00% 0/3 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.

Other adverse events

Other adverse events
Measure	Topical Tazarotene 0.1% Gel Plus BPS n=5 participants at risk * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin	Placebo Gel Plus BPS n=3 participants at risk * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs
Skin and subcutaneous tissue disorders Dry Skin	20.0% 1/5 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	33.3% 1/3 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/5 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	33.3% 1/3 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Skin and subcutaneous tissue disorders psoriasis	0.00% 0/5 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	33.3% 1/3 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	60.0% 3/5 • Number of events 3 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	33.3% 1/3 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Skin and subcutaneous tissue disorders rash	20.0% 1/5 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	0.00% 0/3 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Skin and subcutaneous tissue disorders rash, maculo-papular	0.00% 0/5 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.	33.3% 1/3 • Number of events 1 • 24 weeks Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.

Additional Information

Nicole LeBoeuf, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-6571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place