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RLS-1496 Topical Cream for Actinic Keratosis

This study is testing a topical cream called RLS-1496 1.0% for adults with actinic keratosis (AK), which are rough, scaly patches on the skin caused by sun exposure. Researchers want to see if RLS-1496 cream is safe to use and if it can clear up or reduce the number of AK lesions. You could be eligible if you are an adult with 4-12 AK lesions on each forearm within a specific area, and are willing to follow study instructions. The main goals are to measure the safety of the cream over 57 days and how well it clears AK lesions completely within 29 days. The study is currently unclear on its recruitment status and plans to enroll 24 participants.

Study design
This is an open-label study, meaning you and the researchers will know what treatment you are receiving. It involves 24 participants.
What's involved
You will apply RLS-1496 cream to one forearm daily for 28 days. You will have study visits for assessments, including physical exams and lesion counts.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 28 days after your last application of the study drug, with safety measured up to 57 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07340697

Evaluate RLS-1496 Topical Cream for Actinic Keratosis

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Rubedo Life Sciences, Inc.
~24 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:RLS-1496 1.0% cream

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of multiple doses of topical RLS-1496 cream
Measured over 57 days
+2 more outcomes measured

Conditions

Actinic Keratosis (AK)

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Actinic Keratosis

NCT07340697

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Austin Institute for Clinical Research

    Pflugerville, Texasno site contact published

  • Burke Pharmaceutical Research

    Hot Springs, Arkansasno site contact published

  • Minnesota Clinical Study Center

    New Brighton, Minnesotano site contact published

  • Schlessinger MD Skin Research Center

    Omaha, Nebraskano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mary Spellman, MD · STUDY_DIRECTOR · Acting Chief Medical Officer

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

significant skin disease other than AK which may interfere with interpretation of clinical findings
atypical or rapidly changing AK lesions at the intended treatment and control area (including cutaneous horn, hyperkeratotic, hypertrophic lesions)
clinically relevant co-morbid medical conditions or findings on physical examination or in laboratory analyses
known or suspected pregnancy or lactation (female patients), or planned pregnancy (female and female partners of male patients)
treatment with 5-fluorouracil (5-FU), tirbanibulin, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the intended treatment and control area or within 2 inches (or 5 cm) of the treatment and control area, within 28 days prior to Screening and Day 1visit
treatment with cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing), use of acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, light chemical peels, topical steroids, artificial tanners, or other topical medicinals (non-medicated and non-irritating lotions or creams are permitted) within the intended treatment and control area or within 2 inches (or 5 cm) of the treatment and control area, within 14 days prior to Screening and Day 1 visit
treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate), interferons/interferon inducers, medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 28 days prior to Screening and Day 1 visit
treatment with systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to Screening and Day 1 visit

What this trial measures

  • Safety of multiple doses of topical RLS-1496 cream57 days

    Treatment-emergent adverse events

  • Proportion of individual AK lesions with complete (100%) clearance29 days

    AK lesions with 100% clearance in the treatment and control area at Day 29 (versus pre-dose on Day 1)

  • Complete (100%) clearance of AK lesions29 days

    100% clearance of AK lesions in the treatment and control area at Day 29 (versus pre-dose on Day 1)