RLS-1496 1% cream for actinic keratosis on the forearm
An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis
PHASE1; PHASE2 · Rubedo Life Sciences, Inc. · NCT07340697
This study will test whether applying RLS-1496 1% cream once daily for 28 days to actinic keratosis on one forearm is safe and can reduce or clear lesions in adults.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rubedo Life Sciences, Inc. (industry) |
| Drugs / interventions | infliximab, methotrexate, cyclophosphamide, prednisone |
| Locations | 4 sites (Hot Springs, Arkansas and 3 other locations) |
| Trial ID | NCT07340697 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1/2 study applies RLS-1496 1.0% cream to a defined area on the left dorsal forearm while the right dorsal forearm remains untreated as an internal control. Participants receive a supervised first dose, then apply the cream at home each evening for 28 days and are followed for 28 days after the last application. Investigators will monitor safety (TEAEs, vitals, labs, and local tolerability), count discrete AK lesions in treated and control areas, and collect skin and blood samples for pharmacodynamic and biomarker analyses. The planned enrollment targets adults with 4–12 discrete AK lesions in a 25–100 cm2 area on each dorsal forearm.
Who should consider this trial
Good fit: Adults who have 4–12 visible, discrete actinic keratosis lesions within a 25–100 cm2 area on each dorsal forearm and who can comply with study visits and daily topical application are ideal candidates.
Not a fit: Patients with atypical, rapidly changing, hyperkeratotic or hypertrophic AK lesions, significant other skin disease at the site, recent topical AK treatments, or those who are pregnant or breastfeeding are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, RLS-1496 could provide a once-daily topical option to locally reduce or clear AK lesions with limited systemic exposure.
How similar studies have performed: Other topical agents such as 5‑fluorouracil, imiquimod, and tirbanibulin have shown effectiveness for AK, but RLS-1496 is a novel investigational cream being tested for similar local clearance and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
Where this trial is running
Hot Springs, Arkansas and 3 other locations
- Burke Pharmaceutical Research — Hot Springs, Arkansas, United States (RECRUITING)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (RECRUITING)
- Schlessinger MD Skin Research Center — Omaha, Nebraska, United States (RECRUITING)
- Austin Institute for Clinical Research — Pflugerville, Texas, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Actinic Keratosis