NCT01349556

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2.8 years

First QC Date

May 5, 2011

Last Update Submit

April 21, 2014

Conditions

Medication Reaction

Keywords

cancerchemotherapyEGFR inhibitorstretinoinEGFRi drug rash

Outcome Measures

Primary Outcomes (1)

  • EGFRi rash severity

    8 weeks

Study Arms (1)

Tretinoin pre-treatment

EXPERIMENTAL
Drug: Tretinoin

Interventions

TretinoinDRUG

tretinoin 0.025% cream

Tretinoin pre-treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsNeoplasms

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Anna L Chien, MD

    Johns Hopkins Dermatology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Co-Director, Cutaneous Translational Research Program

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 6, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 23, 2014

Record last verified: 2014-04