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An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis
Led by Rubedo Life Sciences, Inc. · Updated on 2026-01-27
24
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effects of a topical cream called RLS-1496 for adults with actinic keratosis (AK) on their arms. The study aims to find out if applying RLS-1496 once daily for 28 days is safe and whether it reduces or clears AK lesions compared to no treatment. The trial involves comparing treated skin on the left forearm with untreated skin on the right forearm. Participants will apply RLS-1496 cream to a designated area on the left forearm daily for 28 days, starting under supervision and then at home. The right forearm remains untreated as a control. After treatment, participants will be followed for 28 more days. The study includes skin biopsies and assessments of disease markers in the skin and blood. During the study, participants will have clinic visits to monitor safety, count AK lesions on both arms, and undergo physical exams, laboratory tests, and skin evaluations. Local skin reactions and treatment effects will be tracked. The total participation time may last up to 85 days, including screening, treatment, and follow-up. About 24 patients are expected to join the study.
CONDITIONS
Brief Title
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Presence of 4 to 12 clinically typical, discrete, and visible actinic keratosis lesions within a 25 to 100 cm2 area on each dorsal forearm
- Willingness to follow study rules including avoiding other skin treatments and reliably applying the study cream
You will not qualify if you...
- Significant skin diseases other than actinic keratosis that could affect study results
- Atypical or rapidly changing AK lesions at treatment or control areas
- Clinically relevant medical conditions or abnormal lab results
- Known or suspected pregnancy, breastfeeding, or planned pregnancy
- Use of treatments like 5-fluorouracil, imiquimod, or photodynamic therapy near treatment areas within 28 days before screening
- Use of cosmetic or therapeutic skin procedures or certain topical products near treatment areas within 14 days before screening
- Use of immune suppressing or cytotoxic drugs within 28 days before screening
- Use of systemic retinoids within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants apply RLS-1496 1.0% cream to affected areas on the left dorsal forearm under supervision on Day 1 and then apply it at home each evening for a total of 28 applications.
1 supervised application visit and daily at-home applications for 28 days
Duration - 28 days
Participants are followed for safety and treatment effects for 28 days after the last application of the study drug.
Visits for safety and clinical assessments during follow-up period
Trial Site Locations
Total: 4 locations
1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
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2
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
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3
Schlessinger MD Skin Research Center
Omaha, Nebraska, United States, 68144
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4
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
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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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