Evaluate RLS-1496 Topical Cream for Actinic Keratosis

NCT07340697 | Recruiting Phase 1 FDA Drug

• 1 other identifier: RLS-1496-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Actinic Keratosis (AK)

Outcome Measures

Primary Outcomes (3)

• Safety of multiple doses of topical RLS-1496 cream

  Treatment-emergent adverse events

  57 days

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

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

  29 days

• Complete (100%) clearance of AK lesions

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

  29 days

Study Arms (1)

Open-Label Single Arm

EXPERIMENTAL

Bilateral Comparison: Active versus Untreated Control

Drug: RLS-1496 1.0% cream

Interventions

RLS-1496 1.0% cream DRUG

Topical cream to be applied to lesions and peri-lesional skin.

Open-Label Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rubedo Life Sciences, Inc.: lead

Study Sites (4)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

RECRUITING

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

RECRUITING

Schlessinger MD Skin Research Center

Omaha, Nebraska, 68144, United States

RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Spellman, MD

  Acting Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)