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Retinoid

Topical Tazarotene for Hand-Foot Syndrome

Phase 2
Waitlist Available
Led By Vinod Nambudiri, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and day 56
Awards & highlights

Study Summary

This trial is testing whether a medication can prevent a side effect from another medication.

Eligible Conditions
  • Solid Tumors
  • Hand-Foot Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Grade Hand-Foot Skin Reaction (HFSR) Rate
Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate
Secondary outcome measures
Change in HFS-14 Score From Baseline to Day 56
Change in Perceived Stress Scale (PSS) From Baseline to Day 56

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical Tazarotene 0.1% Gel Plus BPSExperimental Treatment1 Intervention
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
Group II: Placebo Gel Plus BPSPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,973 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,769 Total Patients Enrolled
Vinod Nambudiri, MDPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Topical Tazarotene for medical use?

"Based on the available evidence, this Phase 2 trial earned a safety score of two. While there is some data demonstrating its security, no research has yet confirmed its efficacy."

Answered by AI

Have any other trials conducted research on the effects of Topical Tazarotene?

"Presently, there is only 1 active clinical trial for Topical Tazarotene and it resides in the Phase 3 stage. Still, this medication has been tested at one location located within Boston, Massachusetts."

Answered by AI

Is this experiment still open to new participants?

"Affirmative. Clinicaltrials.gov reveals that this medical study, which was initially published on October 9th 2019, is actively seeking applicants. Approximately 70 patients need to be identified from a single site of research."

Answered by AI

What is the current capacity for enrollees in this clinical trial?

"Affirmative. The details hosted on clinicaltrials.gov indicate that the trial is in progress; it was initially posted on October 9th 2019 and last amended on September 9th 2021, with a target of sourcing 70 volunteers from 1 site."

Answered by AI

Has this research protocol been previously explored?

"At present, just one on-going trial exists for Topical Tazarotene. This research is occurring in a single city and nation. The initial study was launched by Bayer in 2019 and involved 70 patients who eventually completed Phase 2 FDA approval. Since then, 18359 trials have been finished with great success."

Answered by AI

What skin conditions is Topical Tazarotene usually prescribed for?

"Topical tazarotene is a successful therapy for acne vulgaris, facial hyperpigmentation, and psoriasis vulgaris."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
Nicole LeBoeuf, MD, MPH 2019. "Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04071756.
~2 spots leftby Apr 2025
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