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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01349556
Enrollment
0
Registered
2011-05-06
Start date
2011-05-31
Completion date
2014-03-31
Last updated
2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Reaction

Keywords

cancer, chemotherapy, EGFR inhibitors, tretinoin, EGFRi drug rash

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.

Interventions

DRUGTretinoin

tretinoin 0.025% cream

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
EGFRi rash severity8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026