A Phase 1/2 interventional study of RLS-1496 1.0% cream in Actinic Keratosis (AK), sponsored by Rubedo Life Sciences, Inc.. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Rubedo Life Sciences, Inc. · Phase 1/2, Interventional, and Treatment
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:
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.
This open-label study is designed to assess the safety, tolerability, and clinical effects, and pharmacodynamic effects of topically applied RLS-1496 1.0% cream for the treatment of AK lesions and perilesional skin on the left dorsal forearm of adults. The right dorsal forearm will remain untreated as a control.
Eligible patients will apply study drug under the supervision of the study staff to the designated affected area on the left dorsal forearm on Day 1 and will be instructed to apply at home starting on Day 2 and each evening thereafter for a total of 28 applications. Patients will be followed for up to 3 months after the last application of study drug.
Safety evaluations will include treatment-emergent adverse events (TEAEs), physical examinations, vital signs, local tolerability assessments, and clinical laboratory assessments.
Clinical assessments of treatment effect will be evaluated at each designated treatment and control area. Local tolerability will be assessed. The Investigator will count discrete AK lesions within the designated treatment and control areas.
Additional assessments will include selected disease-specific biomarkers and markers for target engagement, and senescence in the skin (biopsy and tape stripping), and in the blood.
Following a screening period of up to 28 days, eligible participants will be dosed through Day 28 and followed for an additional 84 days.
Approximately 24 patients will be enrolled in the study.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →This is the only study on the registry with Rubedo Life Sciences, Inc. as lead sponsor.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Bilateral Comparison: Active versus Untreated Control
Drug: RLS-1496 1.0% cream
Topical cream to be applied to lesions and peri-lesional skin.
Safety of multiple doses of topical RLS-1496 cream
Treatment-emergent adverse events
Time frame: 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)
Time frame: 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)
Time frame: 29 days
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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