An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• area on each dorsal forearm with 4-12 clinically typical, discrete and visibly evident AK lesions within a 25-100 cm2 area

• willing to comply with the study requirements, including refraining from use of medications or other treatments for the skin disease (including sun and ultraviolet light exposure), and is able to reliably apply topical medications

Locations
United States
Arkansas
Burke Pharmaceutical Research
RECRUITING
Hot Springs
Minnesota
Minnesota Clinical Study Center
RECRUITING
New Brighton
Nebraska
Schlessinger MD Skin Research Center
RECRUITING
Omaha
Texas
Austin Institute for Clinical Research
RECRUITING
Pflugerville
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 24
Treatments
Experimental: Open-Label Single Arm
Bilateral Comparison: Active versus Untreated Control
Related Therapeutic Areas
Sponsors
Leads: Rubedo Life Sciences, Inc.

This content was sourced from clinicaltrials.gov