Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Medication Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01349556
• Other study ID #: NA_00042104
• Status: Withdrawn
• Phase: N/A
• First received: May 5, 2011
• Last updated: April 21, 2014
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Johns Hopkins Medicine IRB
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Medication Reaction

Intervention

Drug:
• Tretinoin
tretinoin 0.025% cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGFRi rash severity		8 weeks	No