OncoMatch/Clinical Trials/NCT07340697
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Is NCT07340697 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies RLS-1496 1.0% cream for actinic keratosis (ak).
Treatment: RLS-1496 1.0% cream — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: topical therapy for AK (5-fluorouracil, tirbanibulin, imiquimod, ingenol mebutate, diclofenac)
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 1 visit
Cannot have received: photodynamic therapy
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 1 visit
Cannot have received: cosmetic or therapeutic procedures (liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing)
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
Cannot have received: acid-containing therapeutic products (salicylic acid, alpha-hydroxy acids, beta-hydroxy acids, glycolic acids)
use of acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids)
Cannot have received: topical retinoids
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
Cannot have received: topical steroids
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
Cannot have received: artificial tanners
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
Cannot have received: immunomodulator (azathioprine)
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
Cannot have received: cytotoxic chemotherapy (cyclophosphamide, vinblastine, chlorambucil, methotrexate)
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
Cannot have received: interferons/interferon inducers
interferons/interferon inducers
Cannot have received: immunosuppressant (cyclosporine, prednisone, methotrexate, alefacept, infliximab)
medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 28 days prior to Screening and Day 1 visit
Cannot have received: systemic retinoid (isotretinoin, acitretin, bexarotene)
treatment with systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to Screening and Day 1 visit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Burke Pharmaceutical Research · Hot Springs, Arkansas
- Minnesota Clinical Study Center · New Brighton, Minnesota
- Schlessinger MD Skin Research Center · Omaha, Nebraska
- Austin Institute for Clinical Research · Pflugerville, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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