Sorafenib-induced Hand- Foot Skin Reaction Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN

NCT06474078

Stevens-Johnson Syndrome Toxic Epidermal Necrolysis

COMPLETED NA

Photobiomodulation in the Treatment of Hand-foot Syndrome

NCT05337423

Erythrodysesthesia Syndrome

TERMINATED NA

Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions

NCT01276314

Drug Hypersensitivity

COMPLETED NA

Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil

NCT01219023

Hand Foot Syndrome Palmar Plantar Erythrodysesthesia

COMPLETED PHASE1

Study to Evaluate the Safety of Colchicine

NCT05335148

Radiation Therapy

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hand-foot Skin Reaction Rash

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

urea 40% cream applied twice per day to affected areas

Intervention Type DRUG

fluocinonide 0.05% cream

fluocinonide 0.05% cream applied twice per day to affected areas

Intervention Type DRUG

tazarotene 0.1% cream

tazarotene 0.1% cream applied twice per day to affected areas

Intervention Type DRUG

bland emollient cream (Udderly smooth® Udder Cream)

bland emollient cream applied twice per day to affected areas

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

carmol 40 tazarac Udderly smooth® Udder Cream

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
* Subjects must be 18 years or older.
* Patients must provide written informed consent to participate in the study.
* Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
* Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria

* Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
* Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
* Patients with pre-existing dermatological condition affecting the hands or feet.
* Women who have a positive pregnancy test or are lactating.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No