Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
The goal of this clinical trial is to learn if using topical tretinoin will help patients with solid tumors 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant aged ≥ 18 years
Histologically confirmed solid tumor.
Radiologically confirmed locally advanced or metastatic disease.
Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care.
Disqualifiers
Treatment with an anti-EGFR agent within 90 days of registration.
Pre-existing facial rash that per the treating investigator would preclude the ability to assess response to topical tretinoin.
The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Topical Tretinoin
DrugTopical 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.
Placebo
Other interventionA 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Tretinoin half of face (left) and Placebo/Moisturizer other half of the face (right)Experimental treatment 1 intervention
Group B: Tretinoin half of face (right) and Placebo/Moisturizer other half of the face (left)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 6 weeks from the initiation of study therapySecondary outcomes
1
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
Time frame
up to 6 weeks from the initiation of study therapy2
Proportion of acneiform rash per CTCAE v5.0
To assess the safety and tolerability of topical tretinoin in the study population. This outcome measure will report the frequency of acneiform rash as defined by the NIH CTCAE, version 5.0.
Time frame
up to 6 weeks from the initiation of study therapySponsors and contacts
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Source ClinicalTrials.gov