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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Primary Purpose

Medication Reaction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tretinoin
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Reaction focused on measuring cancer, chemotherapy, EGFR inhibitors, tretinoin, EGFRi drug rash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or over
  • Scheduled to begin treatment with an EGFR inhibitor drug

Exclusion Criteria:

  • Pregnant or nursing
  • History of bleeding disorder
  • History of keloids or large, thick, puffy-looking scars in the last 10 years
  • Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tretinoin pre-treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    EGFRi rash severity

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2011
    Last Updated
    April 21, 2014
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01349556
    Brief Title
    Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
    Official Title
    Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn due to volunteer disinterest in participating.
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    5. Study Description

    Brief Summary
    This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib. Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash. Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Medication Reaction
    Keywords
    cancer, chemotherapy, EGFR inhibitors, tretinoin, EGFRi drug rash

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tretinoin pre-treatment
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tretinoin
    Intervention Description
    tretinoin 0.025% cream
    Primary Outcome Measure Information:
    Title
    EGFRi rash severity
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or over Scheduled to begin treatment with an EGFR inhibitor drug Exclusion Criteria: Pregnant or nursing History of bleeding disorder History of keloids or large, thick, puffy-looking scars in the last 10 years Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anna L Chien, MD
    Organizational Affiliation
    Johns Hopkins Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

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