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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06358677
Other study ID # HCI171997
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 2024
Est. completion date July 2029

Study information

Verified date April 2024
Source University of Utah
Contact Susan Sharry
Phone 801-585-3453
Email susan.sharry@hci.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment. Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical Tretinoin
Topical tretinoin will be applied to one half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
Other:
Placebo
A placebo (topical moisturizer) will be applied to the other half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.

Locations

Country Name City State
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment. Effect of topical tretinoin on anti-EGFR induced acneiform rash. Rash will be scored from 0-4 with 0 being clear skin and 4 being a severe rash. 6 weeks
Secondary Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment. Proportion of acneiform rash per CTCAE v5.0 6 weeks
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