Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

NCT ID: NCT01349556

Last Updated: 2014-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Medication Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tretinoin pre-treatment

Group Type EXPERIMENTAL

Tretinoin

Intervention Type DRUG

tretinoin 0.025% cream

Interventions

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Tretinoin

tretinoin 0.025% cream

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Anna Chien

Assistant Professor, Co-Director, Cutaneous Translational Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna L Chien, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Dermatology

Other Identifiers

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NA_00042104

Identifier Type: -

Identifier Source: org_study_id

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