Arcutis
One product, the highest response rates in this register, the cleanest tolerability profile in it, and the worst price in it. All three at once.
MODEL
New Drug Application, manufactured product, retail pharmacy dispensing on a prescriber's script.
The brand verdict
One product assessed. Zoryve foam is roflumilast 0.3%, a steroid-free phosphodiesterase-4 inhibitor approved for seborrhoeic dermatitis and for plaque psoriasis of the scalp and body — and it brought into this register a condition the register had entirely ignored, which is the one most common in the readership it is written for.
The numbers are the best here. Treatment success at eight weeks of 79.5% and 73.1% against 58.0% and 40.8% on vehicle foam. Itch reduction of at least four points in 62.8% of affected subjects against 40.6%. Scalp psoriasis success of 66.4% and 56.7% against 27.8% and 11.0%. Four trials across two indications, with confidence intervals on every difference and named trial registrations throughout.
The tolerability is the second finding and arguably the more remarkable one. Across 458 subjects treated for eight weeks on inflamed facial skin and scalp, no local skin reaction was reported at or above 1%. What appears instead — nasopharyngitis, nausea, headache, all just above 1% — is the systemic signature of PDE4 inhibition. And 408 subjects continued to 24 to 52 weeks with a consistent profile.
Then the can. One 60 g pressurised can, average retail near $1,144, discount pricing near $932, no generic, for a condition many people currently manage with an antifungal shampoo costing under fifteen dollars — a comparison the trials never ran. With coverage or copay assistance the case is straightforward. Paying cash, it is the hardest arithmetic in this register.
- 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 with its own published numbers.
- Named trial registrations for all four studies across two indications.
- No local skin reaction reported at or above 1% across 458 treated subjects.
- 408 subjects followed to 24 to 52 weeks in an open-label extension.
- Steroid-free, with no duration limit imposed by the drug class.
- One product licensed for face, body and hair-bearing scalp.
- An explicit contraindication in Child-Pugh B or C liver impairment.
- Flammability of the propellant stated in the dosing section itself.
- The most representative trial population in this register by ethnicity and age range.
The range
- R-492026-08-02
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.
CONDITIONAL$932 PER 60 G CAN
What repeats across the range
These are the findings a single review cannot make. Each one appears in more than one product, and each is drawn from the reviews above rather than from an impression of the brand.
- 01
A steroid-free anti-inflammatory changes the treatment model
Seborrhoeic dermatitis is lifelong and relapsing, and the historical options are antifungals and topical corticosteroids — the second of which cannot be used indefinitely on a face. A PDE4 inhibitor carries none of the atrophy, telangiectasia or perioral dermatitis constraints, which converts a course into a regimen.
- 02
The highest vehicle arm in the register sits beside the highest drug arm
79.5% on drug and 58.0% on vehicle foam in the same trial. The drug clearly works — the difference is 20.6 points with a confidence interval excluding zero — and nearly three in five subjects improved on plain foam applied consistently. Both columns are published and both are worth knowing before spending a thousand dollars.
- 03
Nothing local above one per cent
Applied daily to inflamed facial skin and hair-bearing scalp for eight weeks, across 458 subjects, no local skin reaction reached 1%. Against Aklief's 65% actively assessed erythema and Tri-Luma's 41%, this is a different order of tolerability, and the 408-subject extension to 24 to 52 weeks supports it.
- 04
Better representation than the rest of this register
79% White, 11% Black, 5% Asian, 21% Hispanic or Latino, with an age range from 9 to 87. Set against Soolantra at 96% Caucasian, Mirvaso at 99% and Finacea Foam at 95.7%, this is the most representative trial population we have recorded — which matters particularly in a condition that presents differently in more pigmented skin.
- 05
The price is the whole objection
One 60 g can, no generic, around $932 to $1,144. Every criterion except cost scores in the mid-eighties. No efficacy result makes a thousand-dollar can of foam a straightforward recommendation, and the trials never tested it against the ketoconazole shampoo it is competing with.
Disclosure scorecard
Not what is in the product — what the company publishes about it, and where. “Findable” means the concentration exists somewhere, such as a help-centre article, rather than on the page you buy from.
SCROLL THE TABLE SIDEWAYS
| PRODUCT | CONC. ON PAGE | CONC. FINDABLE | CONTRA-INDICATIONS | SIZE | SIDE EFFECTS |
|---|---|---|---|---|---|
| Zoryve Foam | YES | YES | YES | YES | YES |
If you buy one
Zoryve Foam
Worth buying for a specific person with a specific problem. Read who.
Zoryve Foam
Worth buying for a specific person with a specific problem. Read who.