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UAB30 for Non-Melanoma Skin Cancer

Phase 1 & 2
Waitlist Available
Led By Craig Elmets, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Potential subjects will have at least 8 actinic keratoses (as determined by study dermatologists or qualified designee)
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (randomization) to day 112
Awards & highlights

Study Summary

This trial is testing a new drug, UAB30, to see if it can help reduce the risk of skin cancer in people who have a history of the disease. The study will last for five years and will compare the effects of UAB30 to a placebo.

Who is the study for?
This trial is for adult renal transplant recipients with skin damage and a history of non-melanoma skin cancer. They must use two effective forms of birth control, have at least 8 actinic keratoses, be in good health with normal organ function, and not be breastfeeding or HIV-positive. People taking certain medications or those who've had other cancers within the last 5 years (except some skin cancers) can't join.Check my eligibility
What is being tested?
The study tests if UAB30 reduces biomarkers related to cell growth and death more effectively than a placebo over 28 days. It's double-blind, meaning neither participants nor researchers know who gets UAB30 or placebo. The focus is on changes in genes responsive to all trans-retinoic acid and effects on DNA damage response and Src signaling pathways.See study design
What are the potential side effects?
While specific side effects are not listed here, retinoids like UAB30 may cause dryness of the skin, lips, eyes; sensitivity to sunlight; headaches; muscle pains; temporary hair thinning; raised levels of fats in the blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have at least 8 actinic keratoses, as confirmed by the study dermatologists or someone qualified to do so.
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You should be able to perform everyday activities without any help or only need a little help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (randomization) to day 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (randomization) to day 112 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of subjects that achieve at least a 30% reduction in cyclin D1 expression in normal skin, in sun-exposed skin, and in actinic keratoses from baseline to the end of UAB30 administration (day 28)
Secondary outcome measures
Mean number of toxicities experienced by subjects in each group treatment with UAB30 without signs of significant toxicity in organ transplant recipients..
Number of subjects in each group with actinic keratosis at the end of treatment with UAB30 (day 28) and 84 days after the end of treatment with UAB30 (day 112).
Percent of subjects with 30% or greater change in all trans-retinoic acid target genes : (ATRA) responsive genes (DHRS3, STRA6, MUC21, GABRP, DHRS9)
+20 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Renal Transplant subjects receiving UAB30Active Control1 Intervention
Generally healthy renal transplant subjects receive UAB30 for 28 days with increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses and presence at baseline of at least 8 actinic keratosis on the face, neck, scalp and arms.
Group II: Renal Transplant subjects receiving placeboPlacebo Group1 Intervention
Generally healthy renal transplant subjects receive placebo for 28 days with increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses and presence at baseline of at least 8 actinic keratosis on the face, neck, scalp and arms.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,411 Total Patients Enrolled
4 Trials studying Non-melanoma Skin Cancer
186 Patients Enrolled for Non-melanoma Skin Cancer
Craig Elmets, MD4.86 ReviewsPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
2 Previous Clinical Trials
94 Total Patients Enrolled
1 Trials studying Non-melanoma Skin Cancer
24 Patients Enrolled for Non-melanoma Skin Cancer
5Patient Review
Dr. Elmets has been my go-to dermatologist for the last five years as I manage my ocular cicatricial pemphigoid. He's always been very compassionate and interested in helping me heal. He's also great about staying up-to-date on the latest drugs and treatments, and he always gives me a few options to choose from when it comes to my care plan. I really appreciate everything he's done for me.

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03327064 — Phase 1 & 2
Non-melanoma Skin Cancer Research Study Groups: Renal Transplant subjects receiving UAB30, Renal Transplant subjects receiving placebo
Non-melanoma Skin Cancer Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03327064 — Phase 1 & 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03327064 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently included in this research endeavor?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was introduced to the public on October 1st 2020, is actively accepting participants. 84 individuals need to be recruited from a single location for the study's completion."

Answered by AI

Are any new participants being enrolled in this investigation?

"Correct. The entry on clinicaltrials.gov confirms that this medical study, initially posted in October 2020, is recruiting patients. Eighty-four individuals need to be enrolled at a single site."

Answered by AI
~0 spots leftby Mar 2025