RLS-1496 Cream for Sunspots
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a cream called RLS-1496 to determine if it can safely reduce or eliminate sunspots, specifically actinic keratoses (AK), which are rough skin patches caused by sun exposure. Participants will apply the cream daily to one forearm for 28 days, while the other forearm remains untreated for comparison. The trial seeks individuals with 4 to 12 visible AK lesions on each forearm who can adhere to the study's guidelines, such as avoiding other skin treatments during the trial. The primary goal is to assess whether the cream can significantly reduce the number of sunspots without causing harm. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.
Will I have to stop taking my current medications?
Yes, you will need to stop using certain medications and treatments for skin conditions, especially those for actinic keratoses, before and during the trial. There are specific timeframes for stopping these treatments, such as 14 to 28 days before the trial starts, depending on the type of medication.
Is there any evidence suggesting that RLS-1496 cream is likely to be safe for humans?
A previous study tested RLS-1496 cream for safety in treating skin conditions like plaque psoriasis and eczema. Participants generally tolerated it well, with some experiencing mild skin irritation, but no serious side effects were reported. The FDA has approved this cream for these conditions, supporting its safety.
The current trial is evaluating RLS-1496 for treating sunspots (actinic keratoses). As an early phase study, the primary focus is on safety. While results appear promising, researchers are still gathering complete safety data. However, earlier studies on similar conditions suggest it is likely safe for most people.12345Why do researchers think this study treatment might be promising?
RLS-1496 Cream is unique because it introduces a novel approach to treating sunspots by using a topical application that directly targets the affected skin areas. Unlike current treatments like cryotherapy or laser therapy, which can be invasive or require multiple sessions, RLS-1496 offers a non-invasive option that patients can apply themselves. Researchers are excited about its potential to provide effective results with minimal side effects, making it a convenient and accessible alternative for managing sunspots.
What evidence suggests that RLS-1496 cream might be an effective treatment for actinic keratoses?
Studies have shown that RLS-1496 cream may help reduce or eliminate actinic keratosis (AK) spots. AKs are rough, scaly patches on the skin caused by sun exposure. In this trial, participants will apply RLS-1496 cream to one side of their body, leaving the other side untreated as a control. The cream targets specific proteins to combat these skin spots. Early findings suggest that daily use of RLS-1496 might effectively decrease the number of AKs. Although more research is needed, the initial results offer promise for those with sun-related skin damage.13678
Who Is on the Research Team?
Mary Spellman, MD
Principal Investigator
Acting Chief Medical Officer
Are You a Good Fit for This Trial?
Adults with actinic keratosis (AK) on their arms can join this trial. They must have 4-12 typical AK lesions within a specific area size on each forearm and be willing to follow study rules, including not using other skin treatments or exposing the area to sun/UV light.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply RLS-1496 cream to the left forearm once daily for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RLS-1496
Trial Overview
The trial is testing RLS-1496 cream's safety and effectiveness for treating AK when applied daily for 28 days. The left forearm gets the cream, while the right arm serves as a control. Researchers will count lesions and take skin biopsies before and after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Bilateral Comparison: Active versus Untreated Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rubedo Life Sciences, Inc.
Lead Sponsor
Citations
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
This clinical trial will assess the safety and tolerability of topical application of RLS-1496 cream to lesions and adjacent skin on the left ...
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
This open-label study is designed to assess the safety, tolerability, and clinical effects, and pharmacodynamic effects of topically applied RLS ...
RLS-1496 Cream for Sunspots
The trial is testing RLS-1496 cream's safety and effectiveness for treating AK when applied daily for 28 days. The left forearm gets the cream, while the right ...
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thedermdigest.com
thedermdigest.com/u-s-fda-clears-ind-for-rubedos-rls-1496-for-ak-dr-emma-guttman-yassky-joins-companys-clinical-advisory-board/U.S. FDA Clears IND for Rubedo's RLS-1496 for AK
The FDA has cleared the IND application for a Phase 1b/2a study of Rubedo Life Sciences' RLS-1496 in patients with actinic keratosis (AK).
Rubedo Life Sciences Announces U.S. FDA Clearance of ...
IND clearance marks second study accepted for RLS-1496, a first-in-class disease-modifying selective GPX4 modulator targeting pathological ...
NCT07340697: An ongoing trial by Rubedo Life Sciences, ...
Full data ; An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis.
Rubedo Life Sciences Announces U.S. FDA Clearance ...
The first EMA-cleared RLS-1496 clinical trial began in May 2025 for plaque psoriasis, atopic dermatitis, and skin aging (photoaged skin); study ...
RLS-1496 - Drug Targets, Indications, Patents
Phase 1 study with topical cream RLS-1496 in patients with plaque psoriasis or Eczema. 100 Clinical Results associated with RLS-1496.
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