Actively Recruiting
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Led by Rubedo Life Sciences, Inc. · Updated on 2026-01-27
24
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial will assess the safety and tolerability of topical application of RLS-1496 cream to lesions and adjacent skin on the left forearm of adults with actinic keratoses (AK) on the arms. The right forearm will remain untreated as a control. The therapeutic objective of topical treatment with RLS-1496 cream is to clear or decrease the number of AK in the treated area, per lesion counts performed by the Investigator. The main questions it aims to answer are: * Is it safe to apply topical RLS-1496 cream to treat AK once daily for 28 days? * Does topical RLS-1496 lower the number of AKs or eliminate AKs in a treated area when applied once daily for 28 days? Researchers will compare results on the left (treated with RLS-1496) and right (no treatment) forearm. Participants will apply RLS-1496 to an identified area on the left forearm once each day for 28 days and have intermittent clinic visits to examine the arms and have the AK lesions counted until 28 days after the last application of RLS-1496. Participants will also have small skin biopsies on the arms.
CONDITIONS
Official Title
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with an area on each dorsal forearm containing 4 to 12 visible, typical actinic keratosis lesions within 25 to 100 cm2
- Willing and able to follow study requirements, including avoiding other skin treatments and reliably applying topical medication
You will not qualify if you...
- Presence of significant skin diseases other than actinic keratosis that could affect study results
- Atypical or rapidly changing AK lesions at the treatment or control sites
- Relevant medical conditions found by physical exam or lab tests
- Known or suspected pregnancy or breastfeeding, or planned pregnancy for female participants or female partners of male participants
- Treatment with certain AK therapies (5-fluorouracil, tirbanibulin, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy) near the treatment sites within 28 days before screening
- Use of cosmetic or therapeutic skin procedures or products (like liquid nitrogen, chemical peels, topical steroids, retinoids, or artificial tanners) near treatment sites within 14 days before screening
- Use of immunosuppressive or cytotoxic medications within 28 days before screening
- Use of systemic retinoids within 6 months before screening
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
2
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
3
Schlessinger MD Skin Research Center
Omaha, Nebraska, United States, 68144
Actively Recruiting
4
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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