Mayne Pharma
Two products, both for rosacea, at opposite ends of what a registration programme can return. One published a demanding endpoint honestly and the honest answer was 12% to 18%. The other put benzoyl peroxide inside silica capsules and got the second-best rosacea result in this register.
MODEL
New Drug Application, manufactured product, retail pharmacy dispensing on a prescriber's script.
The brand verdict
One product assessed. Rhofade is oxymetazoline hydrochloride 1%, a vasoconstrictor for the persistent facial erythema of rosacea — one of only two approved treatments for the part of rosacea patients most want fixed and topicals have least to offer.
The trial design deserves credit before the result gets criticised. Success required at least a two-grade improvement on both the clinician's and the subject's erythema scales, at hours 3, 6, 9 and 12 after dosing on day 29. Both scales, two grades, four timepoints. A single measurement three hours after application would have flattered the drug considerably; the sponsor chose the demanding version and published every cell.
The result is 12% to 18% on drug against 5% to 9% on vehicle. Consistent, roughly double, statistically real, and very small. At its best timepoint in its best trial the drug produced a clearly visible improvement in fewer than one user in five, for part of a day, after which it wears off and the vessels dilate again.
Three warning categories narrow the market further, and they land squarely on this readership: cautions in cardiovascular disease, orthostatic hypotension and uncontrolled blood pressure; in Raynaud's phenomenon, scleroderma, Sjögren's syndrome, thromboangiitis obliterans and cerebral or coronary insufficiency; and an increased risk of angle closure glaucoma in narrow-angle glaucoma. One per cent of subjects also reported worsening inflammatory lesions of rosacea — small, specific, and exactly the failure mode people fear with vasoconstrictors.
- One of only two approved treatments for the persistent facial erythema of rosacea.
- A demanding prespecified composite endpoint, measured at four timepoints rather than one.
- Every timepoint in both trials published, with the vehicle arm beside it.
- Both salt and free-base concentrations stated.
- 440 subjects followed for up to one year in an open-label extension.
- Worsening of inflammatory rosacea published as an adverse reaction.
- Three warning categories published that materially narrow the eligible population.
- An authorised generic exists.
The range
- R-522026-08-02
Epsolay
MICROENCAPSULATED BENZOYL PEROXIDE CREAM 5%Benzoyl peroxide is the last thing you would put on rosacea skin. Sealed inside silica microcapsules that release it slowly, it produced 47.4% and 49.2% treatment success with application-site pain in 2% of users. This is the best formulation engineering in the register.
RECOMMENDED$563 PER 30 G AIRLESS PUMP
- R-412026-08-02
Rhofade
OXYMETAZOLINE HYDROCHLORIDE CREAM 1%A vasoconstrictor for the redness of rosacea, and the only product in this register whose own registration trials show fewer than one user in five reaching the endpoint. It does not treat the disease. It constricts the vessels for part of a day, every day, for as long as you keep applying it.
CAUTION$150 PER TUBE
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
The endpoint was made hard on purpose
Two scales, a two-grade improvement on each, at four timepoints across twelve hours. For a drug whose effect is temporary, that is the design that tells the truth rather than the one that flatters. It is a genuinely good piece of trial construction.
- 02
And the honest answer was small
12% to 18% against 5% to 9%. This is the lowest primary endpoint result for any product in this register, published in full at every timepoint in both trials. Excellent disclosure and a poor result are not in tension — the disclosure is how we know the result.
- 03
It treats appearance, not disease
Alpha-adrenergic vasoconstriction narrows the vessels for a number of hours. Nothing about the underlying vascular hyperreactivity changes. The label is straightforward about the mechanism; the framing of what that means for a chronic condition is left to the reader.
- 04
The warnings fall on the people most likely to want it
Rosacea coexists with Raynaud's and connective tissue disease more often than chance, and midlife is when blood pressure becomes a live question. A daily facial vasoconstrictor is not a cosmetic decision for anyone in those groups, and the label states all three categories clearly enough that a prescriber has no excuse for missing them.
- 05
The other product is the formulation argument in one tube
Epsolay is 5% benzoyl peroxide — the standard cause of topical intolerance — sealed in silica microcapsules that meter its release, applied daily to the least tolerant skin in dermatology. Application-site pain in 2%, erythema in 2%, and treatment success of 47.4% and 49.2%. The concentration on the carton is unremarkable; what reaches the skin is the whole product.
- 06
Both trial populations are the disease's own
Epsolay enrolled 733 subjects with a mean age of 51 and a range of 18 to 85. Rhofade enrolled adults with moderate to severe persistent erythema. Rosacea is a midlife condition and both programmes were recruited accordingly — which, across this register, is rarer than it should be.
- 07
Nothing about stopping
The label offers no guidance on discontinuation. Rebound erythema is well documented for brimonidine, the other approved treatment for rosacea erythema, and is not established for oxymetazoline in these trials — 440 subjects were followed for up to a year. That is an absence of evidence rather than evidence of absence, and it is worth raising before starting.
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.
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