Actinic Keratosis (AK)Phase 1/2NCT07340697
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
A Phase 1/2 study testing RLS-1496 1.0% cream in people with Actinic Keratosis (AK), run by Rubedo Life Sciences, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- RLS-1496 1.0% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Feb 2026to Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Schlessinger MD Skin Research Center
Omaha, Nebraska, 68144
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
About this study
Official title: An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of 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 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- RLS-1496 1.0% cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-1496 1.0% creamDrug
Topical cream to be applied to lesions and peri-lesional skin.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Single Arm | Experimental | Bilateral Comparison: Active versus Untreated Control Receives: Drug: RLS-1496 1.0% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of multiple doses of topical RLS-1496 cream
Treatment-emergent adverse events
Measured: 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)
Measured: 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)
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start3 Feb 2026
- Primary completion27 May 2026
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis (AK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubedo Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Spellman, MD, Study director, Acting Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340697
- Sponsor's protocol ID
- RLS-1496-102
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT07340697
- Acronym / sponsor ID
- RLS-1496-102
- Conditions
- Actinic Keratosis (AK)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rubedo Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Single Arm | Experimental | Drug: RLS-1496 1.0% creamBilateral Comparison: Active versus Untreated Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLS-1496 1.0% creamTopical cream to be applied to lesions and peri-lesional skin. | Drug | Open-Label Single Arm |
Primary outcome
Safety of multiple doses of topical RLS-1496 cream
Time frame: 57 days
Treatment-emergent adverse events
Proportion of individual AK lesions with complete (100%) clearance
Time frame: 29 days
AK lesions with 100% clearance in the treatment and control area at Day 29 (versus pre-dose on Day 1)
Complete (100%) clearance of AK lesions
Time frame: 29 days
100% clearance of AK lesions in the treatment and control area at Day 29 (versus pre-dose on Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Spellman, MD study director
Acting Chief Medical Officer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RLS-1496 1.0% cream in people with Actinic Keratosis (AK), run by Rubedo Life Sciences, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of multiple doses of topical RLS-1496 cream (time frame: 57 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.