NCT07340697 Evaluate RLS-1496 Topical Cream for Actinic Keratosis
| NCT ID | NCT07340697 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rubedo Life Sciences, Inc. |
| Condition | Actinic Keratosis (AK) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mary Spellman, MD
STUDY DIRECTOR
Acting Chief Medical Officer
Frequently Asked Questions
Who can join the NCT07340697 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Actinic Keratosis (AK). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07340697 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07340697 currently recruiting?
Yes, NCT07340697 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rubedo Life Sciences, Inc. to inquire about joining.
Where is the NCT07340697 trial being conducted?
This trial is being conducted at Hot Springs, United States, New Brighton, United States, Omaha, United States, Pflugerville, United States.
Who is sponsoring the NCT07340697 clinical trial?
NCT07340697 is sponsored by Rubedo Life Sciences, Inc.. The principal investigator is Mary Spellman, MD at Acting Chief Medical Officer. The trial plans to enroll 24 participants.