RLS-1496 Cream for Sunspots

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Rubedo Life Sciences, Inc.

Must not be taking: 5-FU, Imiquimod, Retinoids, others

Disqualifiers: Pregnancy, Significant skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

Key

I am willing to follow the study rules and not use other skin treatments or expose my skin to sun/UV light.

I have 4-12 visible skin lesions on each forearm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants apply RLS-1496 cream to the left forearm once daily for 28 days

4 weeks

Intermittent clinic visits for examination and lesion counting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Clinic visits for safety evaluations and lesion assessments

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?

Group I: Open-Label Single Arm Experimental Treatment 1 Intervention

Bilateral Comparison: Active versus Untreated Control

Who Is Running the Clinical Trial?

Rubedo Life Sciences, Inc.

Lead Sponsor