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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Not Applicable
Withdrawn
Conditions
Medication Reaction
Interventions
Registration Number
NCT01349556
Lead Sponsor
Johns Hopkins University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Tretinoin pre-treatmentTretinoin-
Primary Outcome Measures
NameTimeMethod
EGFRi rash severity8 weeks
Secondary Outcome Measures
NameTimeMethod
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