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Withdrawn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
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
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
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Withdrawn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Study withdrawn due to volunteer disinterest in participating.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
Learn more about this trial
Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
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