Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01349556

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Reaction	Drug: Tretinoin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tretinoin pre-treatment	Drug: Tretinoin tretinoin 0.025% cream

Arm

Intervention/Treatment

Experimental: Tretinoin pre-treatment

Drug: Tretinoin

tretinoin 0.025% cream

Outcome Measures

Primary Outcome Measures

EGFRi rash severity [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)