Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

StrataXRT® as a Steroid Sparing Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087629
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Larisa Geskin, Columbia University

Brief Summary:
The purpose is to determine if StrataXRT can be used as a steroid sparing agent for the treatment of cutaneous reactions related to acute graft versus host disease (GVHD), cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, acute GVHD or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL or GVHD and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

Condition or disease Intervention/treatment Phase
CTCL GVH - Graft Versus Host Reaction Device: StrataXRT gel Not Applicable

Detailed Description:
Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Post-marketing Surveillance of StrataXRT® Flexible Wound Dressing for Use as a Steroid Sparing Agent
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: CTCL group
Patients with CTCL being treated with mechlorethamine gel will receive StrataXRT gel.
Device: StrataXRT gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

Experimental: Skin Toxicity group
Patients with skin toxicity secondary to chemo/immunotherapy will receive StrataXRT gel.
Device: StrataXRT gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

Experimental: GVHD group
Patients with acute cutaneous graft versus host disease will receive StrataXRT gel.
Device: StrataXRT gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis




Primary Outcome Measures :
  1. Change in Pruritus Visual Analogue Scale (VAS) Score [ Time Frame: Screening through 3 months ]
    The primary objective of this study is to determine whether StrataXRT® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) to 10 (worst imaginable itch)


Secondary Outcome Measures :
  1. Change in SKINDEX-16 Score [ Time Frame: Screening through 3 months ]
    Another objective is to determine if StrataXRT® will improve patient quality of life secondary to symptomatic improvement through the use of the Skindex 16 QOL (a dermatologic quality-of-life instrument) , which is a validated measure where participants self-report from 1 (never) - 5 (all the time) how each of 30 statements describes participants feelings related to their skin condition.

  2. Change in the rate of primary skin reactions [ Time Frame: Screening through 3 months ]
    Change in the rate of primary skin reactions in participants between the topical steroid treatment period, compared to the StrataXRT gel period as evaluated in screening visits

  3. Change in topical steroid use [ Time Frame: Day 30 through 3 months. ]
    Change in topical steroid use during the StrataXRT gel period as reported daily in patient diaries with time, date, and location of topical steroid application.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Ability to sign informed consent document
  • Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
  • Patients with a diagnosis of CTCL who have intractable pruritis
  • Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
  • Patients on chemo/immunotherapy with drug induced rash
  • Patients with cutaneous acute graft versus host disease

Exclusion Criteria:

  • Patients currently undergoing radiotherapy
  • Patients currently receiving oral steroids
  • Patients who are unable to apply topical medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087629


Contacts
Layout table for location contacts
Contact: Grace Ulerio, CCRC 212-305-6593 gu2102@cumc.columbia.edu

Locations
Layout table for location information
United States, New York
Columbia University Medical Center, Department of Dermatology Recruiting
New York, New York, United States, 10032
Contact: Grace Ulerio, CCRC    212-305-8444    gu2102@cumc.columbia.edu   
Principal Investigator: Larisa J Geskin, MD         
Sponsors and Collaborators
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Larisa J Geskin, MD Columbia University Department of Dermatology

Additional Information:
Layout table for additonal information
Responsible Party: Larisa Geskin, Principal Investigator, Columbia University
ClinicalTrials.gov Identifier: NCT04087629     History of Changes
Other Study ID Numbers: AAAR6582
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Clinical Endpoints/ IPD will be assessed based on analysis of photos and evaluation of survey data, including scores from Pruritis VAS and Skindex-16 QOL scales. The scores during topical steroid treatment period will be compared to the scores during the StrataXRT® gel treatment period. Safety endpoints will be evaluated based on report of product related adverse events and subsequent study product interruption.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Larisa Geskin, Columbia University:
CTCL
GVHD
topical steroids
StrataXRT
cutaneous
steroid sparing