Health TrialsbyHealthPanel

Evaluate RLS-1496 Topical Cream for Actinic Keratosis

ConditionActinic Keratosis (AK)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRubedo Life Sciences, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • RLS-1496 1.0% cream

    Drug

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Open-Label Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of multiple doses of topical RLS-1496 cream

Treatment-emergent adverse events

Time frame
57 days
2

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)

Time frame
29 days
3

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)

Time frame
29 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rubedo Life Sciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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