Evaluate RLS-1496 Topical Cream for Actinic Keratosis

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Rubedo Life Sciences, Inc.
Study ID
NCT07340697
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Actinic Keratosis (AK)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RLS-1496 1.0% cream — DRUG
    Topical cream to be applied to lesions and peri-lesional skin.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label Single Arm
    Bilateral Comparison: Active versus Untreated Control

Primary Outcome Measure

Safety of multiple doses of topical RLS-1496 cream [ Time Frame: 57 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Burke Pharmaceutical ResearchHot SpringsArkansas71913
Makenzie Study Coordinator
[email protected]
501-620-4449
Dow Stough, MD (PRINCIPAL_INVESTIGATOR)
Minnesota Clinical Study CenterNew BrightonMinnesota55112
Donna Study Coordinator
[email protected]
763-571-4200
Steven Kempers, MD (PRINCIPAL_INVESTIGATOR)
Schlessinger MD Skin Research CenterOmahaNebraska68144
Kayleigh Study Coordinator
[email protected]
402-697-6597
Joel Schlessinger, MD (PRINCIPAL_INVESTIGATOR)
Austin Institute for Clinical ResearchPflugervilleTexas78660
Alivia Study Coordinator
[email protected]
512-279-2545
Edward (Ted) Lain, MD, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
Burke Pharmaceutical Research· Hot Springs, ARMinnesota Clinical Study Center· New Brighton, MNSchlessinger MD Skin Research Center· Omaha, NEAustin Institute for Clinical Research· Pflugerville, TX

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