Arcutis / Zoryve Foam
ROFLUMILAST TOPICAL FOAM 0.3%
The strongest efficacy result in this entire register — 79.5% treatment success against 58% on vehicle — with no local skin reaction reported above 1%, on the one very common midlife skin condition the register had entirely ignored. Then look at the price.
Worth buying for a specific person with a specific problem. Read who.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. Establish the covered price before the pharmacy fills it — cash and covered prices for this product differ by an order of magnitude.
The verdict
Seborrhoeic dermatitis is the condition nobody writes about and almost everyone over thirty has met: the flaking at the sides of the nose, the eyebrows, the hairline, the scaly scalp that shampoo half-fixes. It has been treated for decades with antifungals and topical steroids, neither of which is a good long-term answer for facial skin. This is a once-daily, steroid-free PDE4 inhibitor approved for it, and the numbers are the best we have recorded.
In two vehicle-controlled trials in 683 subjects, treatment success at eight weeks — clear or almost clear plus a two-grade improvement — reached 79.5% and 73.1%, against 58.0% and 40.8% on vehicle foam. Among those with meaningful itch at baseline, 62.8% achieved at least a four-point reduction against 40.6%. No other product in this register comes close to those response rates.
The tolerability is the second surprise. Adverse reactions occurring in at least 1% of the 458 treated subjects were nasopharyngitis at 1.5%, nausea at 1.3% and headache at 1.1%. There is no local skin reaction on that list — not erythema, not stinging, not scaling. For a facial product used on inflamed, already-flaking skin, that is remarkable, and 408 subjects continued for 24 to 52 weeks in an open-label extension with a consistent profile.
What makes this conditional is entirely financial. A single 60 g can carries an average retail price near $1,144, with discount-card pricing around $932. The same can is approved for scalp and body plaque psoriasis as well, where scalp success reached 66.4% and 56.7% against 27.8% and 11.0% — genuinely excellent — but no efficacy result makes a thousand-dollar can of foam a straightforward recommendation for a condition many people have managed for years with an over-the-counter shampoo.
- The highest treatment-success rates in this register: 79.5% and 73.1%.
- Both vehicle arms published, including the one that reached 58%.
- Confidence intervals published on every treatment difference.
- A separate, prespecified itch endpoint reported with its own numbers.
- No local skin reaction reported above 1% across 458 treated subjects.
- 408 subjects continued for 24 to 52 weeks with a consistent adverse reaction profile.
- Steroid-free, so it carries none of the duration limits that constrain facial corticosteroids.
- One product for face, body and hair-bearing scalp.
- Two indications, each with its own pair of trials and its own published results.
- Trial demographics published, including 11% Black and 5% Asian subjects — better representation than most of this register.
- An explicit contraindication in Child-Pugh B or C liver impairment.
- Named trial registrations for all four studies.
- Around $932 to $1,144 for a single 60 g can, with no generic.
- Both seborrhoeic dermatitis trials ran eight weeks on a lifelong relapsing condition.
- The vehicle arm reached 58% in one trial, so a large share of the response is not the drug.
- Contraindicated in moderate to severe liver impairment.
- The propellant is flammable — no fire, flame or smoking during and immediately after application.
- Nausea, headache and diarrhoea appear at low rates, which is the systemic signature of PDE4 inhibition.
- No stated treatment duration or stopping point.
- No head-to-head data against ketoconazole, the incumbent standard of care.
Every active, assessed
- Roflumilast0.3% — 3 mg/g
Phosphodiesterase-4 inhibitor — raises intracellular cyclic AMP, suppressing the inflammatory cytokine cascade without a corticosteroid receptor
- BENCHMARK
- 0.3% is the approved foam concentration; a 0.15% cream is approved separately for atopic dermatitis
- ASSESSMENT
- A genuinely different mechanism for a condition previously handled with antifungals and steroids. Because it is not a corticosteroid it carries none of the atrophy, telangiectasia or perioral dermatitis constraints that make facial steroid use a course rather than a regimen — which for seborrhoeic dermatitis, a relapsing lifelong condition, is the whole clinical argument.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| RoflumilastPhosphodiesterase-4 inhibitor — raises intracellular cyclic AMP, suppressing the inflammatory cytokine cascade without a corticosteroid receptor | 0.3% — 3 mg/g | 0.3% is the approved foam concentration; a 0.15% cream is approved separately for atopic dermatitis | A genuinely different mechanism for a condition previously handled with antifungals and steroids. Because it is not a corticosteroid it carries none of the atrophy, telangiectasia or perioral dermatitis constraints that make facial steroid use a course rather than a regimen — which for seborrhoeic dermatitis, a relapsing lifelong condition, is the whole clinical argument. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%84/100
Two randomised, double-blind, vehicle-controlled trials in 683 subjects with a prespecified treatment-success endpoint, a separate published itch endpoint, and a second approved indication supported by two further trials in 736 subjects. The largest response rates in this register. Marked down because both trials ran only eight weeks on a relapsing condition, and because the vehicle arm reached 58% in one of them.
- FORMULATION INTEGRITYWEIGHT 20%86/100
A foam that works on face, body and hair-bearing scalp in one product, at the trialled strength, in a published 60 g can, with no corticosteroid and no local reaction above 1%. Steroid-free is the whole point on facial and scalp skin needing years of treatment. Marked down for the flammable propellant, which the dosing section flags directly.
- DISCLOSUREWEIGHT 15%88/100
Concentration in per cent and mg per gram, fill weight, both indications with their own trials, named trial registrations, treatment success with confidence intervals on every difference, a separate itch endpoint, full trial demographics including 11% Black and 21% Hispanic or Latino subjects, an explicit contraindication, and a long-term extension cohort with its size and duration. Held back only because the cost consequence of a single-can pack is never addressed.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed by us, and the label's own figures are the strongest in the register: nothing local above 1% across 458 treated subjects, with 408 continuing to 24 to 52 weeks. A panel would mostly be confirming it, though the foam's feel on hair-bearing scalp is worth establishing.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. A foam applied to face and scalp is a genuinely different daily experience from a cream and is the main practical reason to choose this format.
- COST PER APPLICATIONWEIGHT 10%26/100
An average retail price near $1,144 for a single 60 g can, discount pricing near $932, no generic. The fill weight is published so cost per gram is computable, and it is the worst arithmetic in this register — for a condition many people currently manage with a shampoo costing under fifteen dollars. Copay assistance and coverage change this entirely, which is itself the reason the sticker price is meaningless unless checked.
What it is
Roflumilast 0.3% in a topical foam, applied once daily to affected areas of body and scalp, approved for seborrhoeic dermatitis from age nine and for plaque psoriasis of the scalp and body from age twelve. A 60 g pressurised can, around $932 with a discount card. It is a phosphodiesterase-4 inhibitor, so it is not a steroid and not an antifungal.
The condition this register had ignored
Forty-eight reviews in, this site had covered acne, rosacea, melasma, photoageing and hypertrichosis, and not seborrhoeic dermatitis — which is one of the most common inflammatory skin conditions there is, peaks in adulthood, and produces exactly the symptoms people misattribute to dryness or to their moisturiser: flaking beside the nose, scaling in the brows, an itchy scalp that responds to medicated shampoo and comes straight back.
The historical options are antifungals, which target the Malassezia component, and topical corticosteroids, which control the inflammation and cannot be used indefinitely on a face. That second constraint is the same one that makes Tri-Luma at R-35 a short-term product. A steroid-free anti-inflammatory that can be used on facial skin for as long as needed is therefore not a marginal improvement — it is a different treatment model.
The best numbers in the register
Success required clear or almost clear plus a two-grade improvement. STRATUM: N=304 against 153. Trial 203: N=154 against 72. Treatment differences of 20.6 points (95% CI 11.2 to 30.0) and 33.8 points (95% CI 20.3 to 47.4).
Both columns deserve attention. Four in five subjects reached clear or almost clear on the drug, which is a response rate nothing else here approaches — and nearly three in five reached it on plain foam in the same trial. Seborrhoeic dermatitis responds substantially to any bland vehicle applied consistently, which is worth knowing before spending a thousand dollars.
On itch, among the two-thirds of STRATUM subjects with a baseline worst-itch score of at least four, a four-point reduction was achieved by 62.8% on drug against 40.6% on vehicle. And the same can, in psoriasis, produced scalp treatment success of 66.4% and 56.7% against 27.8% and 11.0% — where the vehicle arms are far lower and the drug's contribution correspondingly clearer.
Nothing on the local reaction list
Aklief at R-50 records erythema worse than baseline in 65% of subjects. Tri-Luma records erythema in 41%. Altreno's 4% dryness was notable enough to be the point of that review. Here, applied daily to inflamed facial skin and scalp for eight weeks, no local reaction crossed one per cent. What does appear — nausea, headache, diarrhoea, at rates just above one per cent — is the systemic signature of PDE4 inhibition rather than anything happening at the skin.
The long-term extension supports it: 408 subjects continued for 24 to 52 weeks with a profile consistent with the controlled trials. Together with Soolantra at R-40, that makes two products in this register with genuine year-scale safety data — and both are manufactured, and neither is compounded.
The can
One 60 g pressurised can. Average retail near $1,144. Discount-card pricing near $932. No generic.
There is no way to write around that. It is the most expensive single container in this register by some distance, for a condition that a great many people currently manage — imperfectly, but manage — with a ketoconazole or selenium sulfide shampoo costing under fifteen dollars. The trials never compared it against one.
What changes the calculation is coverage. With insurance or manufacturer copay assistance this becomes an ordinary prescription, and at that point the case is straightforward: better response rates than the incumbents, no steroid, no duration limit, one product for face and scalp. Paying cash, it is a very large sum for a condition that is uncomfortable and cosmetically miserable rather than dangerous. That is a real decision and it belongs to the person paying.
If you are considering it
- Establish the covered price before the pharmacy fills it, and ask about copay assistance in the same conversation.
- If you have not run a proper trial of an antifungal shampoo — used as directed, left on, for several weeks — do that first.
- Shake the can. Apply once daily to dry skin, not wet. Rub in completely and wash your hands.
- It goes on face, body and hair-bearing scalp, which is unusual and is a genuine convenience.
- Give it eight weeks. Both trials read out then, and separation was visible before.
- Tell your prescriber about any liver disease — Child-Pugh B or C is a contraindication.
- No fire, flame or smoking during and immediately after application.
- If you have been using a facial steroid for this, discuss how to step off it rather than stopping both at once.
- Ask what happens after eight weeks, because the label sets no duration and the condition relapses.
Where we stand
At 78 this would score in the mid-eighties on evidence, formulation and disclosure alone, and the price criterion takes it down. That is the scoring model working as intended: a genuinely excellent drug that a great many people cannot reasonably buy is not the same as a good purchase.
It is also the clearest demonstration in this register of what a modern registration programme can deliver — four trials across two indications, confidence intervals throughout, a year-scale extension, better ethnic representation than anything else here, and a tolerability profile that a compounded formula could assert but never evidence. If you can get it covered, take it. If you cannot, the shampoo you have not been using properly is still the first move.
The other product here with genuine year-scale safety data.
Why a steroid-free anti-inflammatory changes the treatment model on facial skin.
58% on plain foam — the highest vehicle response in the register.
Who this is for
- Someone with facial or scalp seborrhoeic dermatitis that antifungal shampoos and washes have not controlled.
- Someone who has been cycling topical steroids on their face for seborrhoeic dermatitis and needs to stop.
- Someone with scalp psoriasis, where the S-IGA results are among the strongest available.
- Someone with insurance coverage or copay assistance, which is what makes the price survivable.
- Someone whose skin has reacted badly to everything else — the reaction profile here is the best in the register.
- You are paying full cash and have not yet tried an antifungal shampoo properly.
- You have moderate to severe liver impairment — this is a contraindication, not a caution.
- You want a treatment with published data beyond eight weeks in your condition.
- You need evidence against ketoconazole specifically, which does not exist here.
- You cannot use an aerosol safely — the propellant is flammable.
We earn nothing on this link. Establish the covered price before the pharmacy fills it — cash and covered prices for this product differ by an order of magnitude.
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 — ZORYVE (roflumilast) topical foam, 0.3%, Arcutis Biotherapeutics, Inc. The 0.3% strength stated as 3 mg per gram in a 60 g pressurised can; both indications; the seborrhoeic dermatitis trials STRATUM (NCT04973228) and Trial 203 (NCT04091646) in 683 subjects with IGA treatment success of 79.5% against 58.0% and 73.1% against 40.8% and confidence intervals on both differences; the WI-NRS result of 62.8% against 40.6%; the psoriasis trials ARRECTOR (NCT05028582) and Trial 204 (NCT04128007) with S-IGA success of 66.4% against 27.8% and 56.7% against 11.0%; the adverse reaction table showing nasopharyngitis 1.5%, nausea 1.3% and headache 1.1% with no local skin reaction at or above 1%; the 408-subject open-label extension at 24 to 52 weeks; the contraindication in Child-Pugh B or C liver impairment; the flammability instruction; and the trial demographics including 79% White, 11% Black, 5% Asian and 21% Hispanic or Latino. Read 2 August 2026.
- S-02GoodRx — Zoryve pricing Discount-card pricing from around $932.08 against an average retail price near $1,143.70, with no generic available for the cream or foam. Retrieved 2 August 2026.