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New treatment option for Actinic Keratosis (AK)
Official title Evaluate RLS-1496 Topical Cream for Actinic Keratosis
ClinicalTrials.gov ID: NCT07340697
What this study is testing
What is RLS-1496 1.0% cream?
RLS-1496 1.0% cream is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for actinic keratosis (ak).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- treatment with cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth...
See the full eligibility criteria
- 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...
- 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)...
- 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...
- treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate), interferons/interferon inducers, medications that suppress the immune system (eg...
- treatment with systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to Screening and Day 1 visit
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- New Brighton, Minnesota, United States
- Omaha, Nebraska, United States
- Pflugerville, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hot Springs, Arkansas, United States; New Brighton, Minnesota, United States; Omaha, Nebraska, United States; Pflugerville, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.