Almirall / Klisyri
TIRBANIBULIN OINTMENT 1%
Five days of treatment, then you stop. Complete clearance of actinic keratoses in 44% and 54% of subjects against 5% and 13% on vehicle — and it answers a question R-34 raised and left hanging, because these are the photodamaged patients every anti-ageing trial excluded.
Buy it. The formula, the disclosure and the price all hold up.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. This is a five-day course. If anyone is selling you a monthly version of a field treatment for actinic keratosis, that is the finding.
The verdict
R-34 recorded that Renova's registration trials excluded patients with visible actinic keratosis or a history of skin cancer — which means the population with the most photodamage has no data in the only product approved for photoageing. This is the drug for that population, and its trials enrolled exactly them: 702 adults, average age 70, range 45 to 96, 72% Fitzpatrick I or II.
The efficacy is unambiguous. Complete clearance — no clinically visible actinic keratosis lesions in the treatment field at day 57 — was reached by 44% and 54% of subjects against 5% and 13% on vehicle, with treatment differences of 40 and 42 points. On the face specifically, 50% and 61% against 6% and 14%. These are the largest treatment differences in this register after Latisse.
The format is what makes it remarkable in a register full of subscriptions. Five consecutive days of once-daily application from single-use packets, and then it is over. No maintenance, no monthly billing, no open-ended anything. Subjects who cleared were then followed for twelve months to see whether lesions came back — a question almost nothing else here asks.
The cost is a local skin reaction profile that looks alarming until you read the duration. Erythema worse than baseline in 91% of subjects, flaking in 82%, crusting in 46% — collected independently of adverse events, the same rigorous method Aklief uses at R-50. This is a five-day chemical insult that heals, not a chronic irritation, and the label's grading shows most reactions were mild to moderate. It is still not a treatment to start the week before a wedding.
- A five-day course with a defined end, in a register full of open-ended subscriptions.
- Complete 100% clearance as the primary endpoint, not partial improvement.
- 44% and 54% cleared against 5% and 13% on vehicle — differences of 40 and 42 points.
- Face and scalp results reported separately.
- Unit-dose packets remove the dosing judgement entirely.
- Field treatment addresses subclinical damage, not just visible lesions.
- Subjects who cleared were followed for twelve months for recurrence.
- Local skin reactions collected independently of adverse events and published by severity.
- Explicit warning that severe reactions including vesiculation and ulceration can occur.
- Instruction to avoid use until skin has healed from prior treatment or surgery.
- Trial population is the one that actually has the disease: average age 70, range 45 to 96.
- Erythema worse than baseline in 91% of subjects and flaking in 82%, over the treatment period.
- Severe local reactions in 6% for erythema and 9% for flaking.
- 99% of trial subjects were White and 87% male.
- Around $281 to $1,944 per course depending entirely on how it is bought.
- Occlusion increases irritation, and an ointment on the face invites accidental occlusion.
- The twelve-month recurrence data are collected but not summarised on the label.
- Only one field size was studied — a contiguous 25 cm² area on the face or scalp.
- Treats the field that was treated. It does nothing about the rest of a lifetime of sun exposure.
Every active, assessed
- Tirbanibulin1% — 2.5 mg in 250 mg or 3.5 mg in 350 mg per packet
Microtubule inhibitor — disrupts tubulin polymerisation in rapidly proliferating cells
- BENCHMARK
- 1% is the only approved concentration; there is no ladder
- ASSESSMENT
- A microtubule inhibitor applied as field treatment rather than lesion-by-lesion, so it acts on the subclinical damage around the lesions you can see as well as the lesions themselves. Supplied in unit-dose packets, which removes the dosing judgement entirely — you use one packet, once a day, for five days, and there is nothing left to over-apply.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| TirbanibulinMicrotubule inhibitor — disrupts tubulin polymerisation in rapidly proliferating cells | 1% — 2.5 mg in 250 mg or 3.5 mg in 350 mg per packet | 1% is the only approved concentration; there is no ladder | A microtubule inhibitor applied as field treatment rather than lesion-by-lesion, so it acts on the subclinical damage around the lesions you can see as well as the lesions themselves. Supplied in unit-dose packets, which removes the dosing judgement entirely — you use one packet, once a day, for five days, and there is nothing left to over-apply. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%86/100
Two double-blind vehicle-controlled trials in 702 subjects with a strict primary endpoint — complete, 100% clearance — treatment differences of 40 and 42 points with confidence intervals, face and scalp reported separately, and twelve-month recurrence follow-up for subjects who cleared. Marked down only because 99% of subjects were White and 87% male, which is the population that presents with the disease but narrows the evidence.
- FORMULATION INTEGRITYWEIGHT 20%84/100
Unit-dose packets in two fill weights, so the dose is determined by the packaging rather than the patient — the same problem the metered dispenser at R-45 solves, solved here by a manufacturer. Field treatment rather than spot treatment is the right design for a disease of diffuse damage. Marked down because occlusion increases irritation and the ointment base makes that easy to do accidentally.
- DISCLOSUREWEIGHT 15%90/100
Complete clearance rather than a softer responder endpoint, both trials with registration numbers, face and scalp separated, local skin reactions collected independently of adverse events and published by severity grade, an explicit warning that severe reactions including vesiculation and ulceration can occur, and a recurrence follow-up. Held back because the twelve-month recurrence figures are not summarised on the label itself.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed by us, and the label does the work: erythema worse than baseline in 91% of subjects, flaking in 82%, crusting in 46%, mostly mild to moderate, over a five-day course. A panel would establish the timeline of healing, which is the number a patient actually wants and which no label states.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. An ointment on the face for five days, with an explicit instruction not to occlude, is a practical question worth a panel.
- COST PER APPLICATIONWEIGHT 10%60/100
Around $281 with a discount card against an average retail near $1,944 — a sevenfold spread — for a complete course of five packets. Because it is a course rather than a regimen, the total cost is knowable in advance, which is true of almost nothing else in this register. Expensive per gram, finite per patient.
What it is
Tirbanibulin 1% in an ointment, applied once daily for five consecutive days to a contiguous 25 cm² field on the face or scalp, approved for the field treatment of actinic keratosis. Supplied as a carton of five single-use packets. Around $281 with a discount card. Then it is finished.
The patients every anti-ageing trial excluded
R-34 noted, from Renova's own label, that patients with visible actinic keratosis and patients with a history of skin cancer were excluded from its trials — so the effectiveness and safety of the only FDA-approved topical for facial wrinkles are unknown in the people with the most sun damage. L-10 made the same point more generally: the trial populations behind these products rarely resemble the people buying them.
Average age 70, range 45 to 96, 72% Fitzpatrick I or II, lesions on the face in 68% and the scalp in 32%. That is not a cosmetic population and it is not a young one. It is the population that decades of ultraviolet exposure actually produces, and it is the only programme in this register recruited around that fact rather than around a marketing segment.
The distinction matters for anyone reading this site's anti-ageing reviews. Photoageing and actinic damage are the same process at different points on a continuum, and past a certain point the correct product is not a retinoid you buy for texture — it is a field treatment prescribed after someone has looked at your skin.
Complete clearance, not improvement
Study 1 (NCT03285477): N=175 against 176. Study 2 (NCT03285490): N=178 against 173. The endpoint required no clinically visible lesions remaining in the treatment field — not fewer, none. Treatment differences of 40 points (95% CI 31.6–47.5) and 42 points (95% CI 33.1–50.7).
The face outperforms the scalp consistently, and the label reports both rather than pooling them into a flattering average. That is a clinically useful distinction: someone treating a bald scalp should expect roughly half the clearance rate of someone treating a cheek.
The five days you should plan around
Klisyri N=353, vehicle N=349, collected independently of adverse events and graded by investigators. Bars are the total percentage recording each reaction at any severity; the notes give the split. Most were mild to moderate, over a five-day course that then heals.
Read that table the way the label intends. This is a drug that kills proliferating cells in a field of damaged skin; visible reaction is the treatment working, not a formulation failure, and the five-day limit is what keeps it survivable. The label also warns that severe reactions including vesiculation, pustulation, erosion and ulceration can occur, and that occlusion after application makes irritation more likely.
The local skin reactions above were 'collected independent of adverse events'. The adverse reactions section, listing what subjects volunteered at 2% or more, records only local skin reactions, application site pruritus and application site pain. Two tables, one trial, and a difference of an order of magnitude — exactly the gap Aklief's label exposes. When a product quotes you an irritation rate, the question is always whether anyone was asked or whether anyone looked.
A course, in a register of subscriptions
Five packets. Five days. Then subjects who cleared returned every three months for a year so that recurrence could be measured.
It is worth stopping on how unusual that is here. Fifty-three other reviews in this register describe products with no stated duration, no stated stopping point, or an explicit subscription. Two — Tri-Luma at R-35 and Oracea at R-48 — have a stop written into the label. This one has a stop written into the box: when the fifth packet is gone, the treatment is over, and there is nothing to cancel.
If you are considering it
- Get the lesions examined. Actinic keratosis is a clinical diagnosis with a small but real progression risk, not something to treat on suspicion.
- Plan the five days. Expect visible erythema, flaking and crusting during and after, and do not schedule anything you would rather look well for.
- One packet, once a day, to the whole 25 cm² field — not dabbed on individual lesions.
- Do not cover or occlude the area afterwards; the label says occlusion increases irritation.
- Wash your hands after applying, and keep it away from the eyes, mouth and nostrils.
- Do not start if the skin has not healed from previous treatment or surgery there.
- Check the covered price. Cash and discounted prices here differ roughly sevenfold.
- Ask about follow-up. Clearance at day 57 is not permanence, and the trials measured recurrence for a reason.
- Sunscreen afterwards, permanently. The field you treated is a sample of the damage, not all of it.
Where we stand
At 83 this is the highest-scoring manufactured product in the register bar Tri-Luma, and it earns the position on the least fashionable grounds available: a hard endpoint honestly measured, a population that actually has the disease, a tolerability table that makes the product look worse and was published anyway, and a treatment that ends.
It also closes a loop this site opened at R-34. The only approved topical for facial wrinkles excludes people with actinic damage from its evidence base. If you are over fifty with a lifetime of sun on your face, the honest reading of this register is that the most useful prescription available to you may not be an anti-ageing product at all.
The approved photoageing product whose trials excluded exactly these patients.
The incumbent this displaced — two to four weeks, and no clearance figure on its label.
The other label that collects local skin reactions independently of adverse events.
Trial populations, and how rarely they resemble the people buying the product.
What a treatment with an end looks like.
Who this is for
- Someone with actinic keratoses on the face or scalp who wants a five-day course rather than weeks of treatment.
- Someone who has been putting off field treatment because the older options run for two to four weeks.
- Someone who wants a defined total cost and a defined end date.
- Anyone in this register's readership with significant photodamage, for whom the anti-ageing products here have no data at all.
- You cannot tolerate five days of visible erythema, flaking and crusting on your face.
- Your skin has not yet healed from previous treatment or surgery in the same area.
- You need the treated area covered or occluded for work.
- You are looking for a cosmetic anti-ageing treatment — this is a field treatment for a precancerous lesion and should be prescribed as one.
- You have not had the lesions actually examined. Actinic keratosis is a diagnosis, not a self-assessment.
We earn nothing on this link. This is a five-day course. If anyone is selling you a monthly version of a field treatment for actinic keratosis, that is the finding.
This is an editorial assessment of published information about a prescription product. It is not a diagnosis, not a prescription and not a substitute for your own prescriber. Hydroquinone and tretinoin are drugs. Decisions about them belong with a clinician who has seen your skin.
Sources
- S-01FDA-approved labelling — KLISYRI (tirbanibulin) ointment, 1%, Almirall, LLC The 1% strength as 2.5 mg in 250 mg or 3.5 mg in 350 mg unit-dose packets; the five-day once-daily field-treatment regimen on a 25 cm² area; the two vehicle-controlled trials (NCT03285477, NCT03285490) in 702 subjects with complete clearance at day 57 of 44% against 5% and 54% against 13%, treatment differences of 40 and 42 points with confidence intervals, and face and scalp results reported separately; the demographics of average age 70, range 45 to 96, 99% White, 87% male, 72% Fitzpatrick I or II; the twelve-month recurrence follow-up for subjects who cleared; the local skin reaction table collected independently of adverse events showing erythema at 22% mild, 63% moderate and 6% severe, flaking at 26%, 47% and 9%, and crusting at 30%, 14% and 2%; and the warnings on severe local reactions and occlusion. Read 2 August 2026.
- S-02GoodRx — Klisyri pricing A price as low as $280.79 for a carton of five 350 mg packets with a discount card, against an average retail price near $1,944.18. Retrieved 2 August 2026.