# R-41 — Mayne Pharma 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.

- **Canonical:** https://www.30plusskin.care/reviews/rhofade-oxymetazoline-cream-review
- **Site:** 30+/SKIN — Skincare, published as a spec sheet.
- **Issue:** ISSUE NO. 13 / REV. 2026.10
- **Standing terms:** INDEPENDENT · AFFILIATE-FUNDED · NOT MEDICAL ADVICE

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## Verdict

- **Stance:** CAUTION — There is a real reason to hesitate. Read the finding before you buy.
- **Weighted score:** 62/100 across 75% of the scoring model
- **Score scope:** See assessed criteria
- **Category:** PRESCRIPTION MANUFACTURED / ROSACEA — PERSISTENT FACIAL ERYTHEMA
- **Price:** $150 — PER TUBE · ONCE DAILY, INDEFINITELY
- **Container size:** 30 G
- **Prescription:** yes
- **Compounded:** no
- **Assessment basis:** DESK REVIEW
- **Last updated:** 2026-08-02
- **Manufacturer page:** https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34298db6-647d-480d-88a8-dc53258a5164

The redness of rosacea is the part patients most want fixed and the part topicals have least to offer. Rhofade is one of only two drugs approved for it. It is an alpha-1A adrenergic agonist — a vasoconstrictor — and it works exactly the way that description suggests: it narrows the superficial vessels for a number of hours, and then it wears off.

The trial result is the problem. The primary endpoint was a composite: at least a two-grade improvement on both the clinician's and the subject's erythema assessments, at hours 3, 6, 9 and 12 on day 29. Across two trials of 885 subjects, that was reached by 12% to 18% of treated subjects against 5% to 9% on vehicle. The drug beats vehicle at every timepoint in both trials, consistently and by roughly double. It also means four in five users did not reach the endpoint.

The safety profile is quiet but the warnings are not trivial for this readership. As an alpha-adrenergic agonist it carries cautions in severe or uncontrolled cardiovascular disease, orthostatic hypotension and uncontrolled hypertension or hypotension; in cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma and Sjögren's syndrome; and it may increase the risk of angle closure glaucoma in narrow-angle glaucoma. Rosacea and Raynaud's and Sjögren's are not rare companions.

And 1% of subjects reported worsening inflammatory lesions of rosacea, against under 1% on vehicle. That is a small number, but it is the specific failure mode people fear with vasoconstrictors, and it is on the label rather than in a forum. Combined with a price that reaches $864 at average retail, this is a product to try with clear eyes and a defined review point, not one to start indefinitely because the redness is upsetting.

## Actives, as published

| Active | Concentration | Role | Benchmark | Assessment | Flagged |
| --- | --- | --- | --- | --- | --- |
| Oxymetazoline hydrochloride | 1% | Alpha-1A adrenergic agonist — constricts cutaneous vessels, reducing visible erythema | 1% is the approved and trialled concentration, equivalent to 0.88% free base | Correctly dosed and correctly described. The honest framing is cosmetic rather than therapeutic: it changes how the skin looks while it is working and does nothing to the underlying vascular hyperreactivity. The label states the free-base equivalence, which is the kind of precision the compounded end of this register never offers. | yes |

## Scoring

| Criterion | Weight | Score | Note |
| --- | --- | --- | --- |
| EVIDENCE FOR THE ACTIVE | 30% | 52/100 | Two identical randomised vehicle-controlled trials in 885 subjects, with a demanding composite endpoint measured at four timepoints and consistent separation from vehicle in both — good design, poor yield. Twelve to eighteen per cent success is the lowest primary endpoint result in this register, and the trials ran 29 days against a condition managed for decades. |
| FORMULATION INTEGRITY | 20% | 72/100 | A conventional once-daily cream at the trialled strength, stating both the salt and free-base concentrations, manufactured to pharmaceutical standard with a full excipient list and a stated fill weight. Nothing wrong with it; nothing about the vehicle is doing therapeutic work. |
| DISCLOSURE | 15% | 88/100 | Publishes a composite endpoint most sponsors would have softened, at every timepoint, in both trials, with the vehicle arm beside it. Publishes worsening of inflammatory lesions as an adverse reaction. Publishes three separate warning categories that narrow its own market. States salt and free-base strengths. Marked down only because nothing on the label addresses what happens when treatment stops. |
| TOLERANCE IN USE | 15% | not scorable | Not assessed. Reported reactions through four weeks were low — application site dermatitis 2%, worsening inflammatory lesions 1%, pruritus and erythema 1% each — and 440 subjects were followed for up to a year in an open-label trial. A panel would need to address the question the label does not: what the skin looks like on the days you do not apply it. |
| TEXTURE & WEAR | 10% | not scorable | Not assessed, and it matters more here than usual: this is a morning product worn under sunscreen and make-up all day. |
| COST PER APPLICATION | 10% | 30/100 | An average retail price near $864 with discount-card prices starting around $150 — a five-fold spread on the same tube — for a once-daily cosmetic vasoconstriction that fewer than one user in five will find reaches the trial endpoint. The fill weight is published, so the arithmetic can be done; it does not come out well. |

_A criterion that cannot be assessed from published information is not guessed at. Its weight is removed from the denominator, and the coverage figure above says how much of the model survived._

## Strengths

- One of only two approved treatments for the persistent facial erythema of rosacea.
- Two identical randomised vehicle-controlled trials with a demanding prespecified composite endpoint.
- Effect measured at four timepoints across twelve hours, not once at a convenient moment.
- Consistent separation from vehicle at every timepoint in both trials.
- Both salt and free-base concentrations stated.
- 440 subjects followed for up to one year in an open-label extension.
- Publishes worsening of inflammatory rosacea as an adverse reaction.
- Publishes three warning categories that materially narrow who should use it.
- An authorised generic exists.

## Weaknesses

- Composite success of 12% to 18% — the weakest primary endpoint in this register.
- Controlled trials ran 29 days for a condition managed over years.
- Treats appearance, not disease: vasoconstriction wears off and the erythema returns.
- 1% of subjects reported worsening inflammatory lesions of rosacea.
- Cautioned in cardiovascular disease, orthostatic hypotension and uncontrolled hypertension or hypotension.
- Cautioned in Raynaud's phenomenon, scleroderma, Sjögren's syndrome, thromboangiitis obliterans and cerebral or coronary insufficiency.
- May increase the risk of angle closure glaucoma in narrow-angle glaucoma.
- Average retail near $864, with a five-fold spread depending on how it is bought.
- The label says nothing about what happens on discontinuation.

## Suits

- Someone whose persistent facial erythema is genuinely disabling socially and who has already treated the inflammatory component.
- Someone who will trial it for a defined period with a defined review, rather than starting it open-endedly.
- Someone with no cardiovascular, vascular or narrow-angle glaucoma history, and who has checked.
- Someone who understands they are buying hours of vasoconstriction, not a change in the disease.

## Avoid if

- You have severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension or uncontrolled blood pressure in either direction.
- You have Raynaud's phenomenon, scleroderma, Sjögren's syndrome, thromboangiitis obliterans or cerebral or coronary insufficiency.
- You have narrow-angle glaucoma.
- Your rosacea is primarily papulopustular — R-40 and R-42 treat that, and treat it far better.
- You are paying cash at anything near the average retail price.
- You want a treatment that changes the condition rather than its appearance for part of a day.

## The full assessment

### What it is

Oxymetazoline hydrochloride 1% — the same molecule as the decongestant nasal spray — in a once-daily facial cream, approved for the persistent facial erythema of rosacea in adults. It works by constricting the small vessels in the skin. When it wears off, they dilate again.

**RECORD**

| Field | Value |
| --- | --- |
| BRAND | RHOFADE — MAYNE PHARMA |
| ACTIVE | OXYMETAZOLINE HCL 1% — 10 MG PER GRAM |
| FREE BASE EQUIVALENT | 8.8 MG PER GRAM — 0.88% |
| CLASS | ALPHA-1A ADRENERGIC AGONIST |
| INDICATION | PERSISTENT FACIAL ERYTHEMA OF ROSACEA, ADULTS |
| DOSING | ONCE DAILY |
| TRIAL DURATION | 29 DAYS · 2 TRIALS · N=885 |
| PRIMARY ENDPOINT | COMPOSITE, 4 TIMEPOINTS, DAY 29 |
| PRICE | FROM ~$150 · ~$864 AVERAGE RETAIL |

### The endpoint, and why it is honest

Success required at least a two-grade improvement on both the clinician erythema assessment and the subject self-assessment, measured at hours 3, 6, 9 and 12 after dosing on day 29. Both scales. Two grades. Four timepoints.

That is a hard endpoint, deliberately so, and it is the right way to test a drug whose effect is temporary — a single measurement three hours after application would have flattered it considerably. The sponsor chose the demanding version and published every cell.

**FIG. 1 — COMPOSITE SUCCESS ON DAY 29, BY HOUR** — Trial 1: N=222 against 218 on vehicle. Trial 2: N=224 against 221. The drug roughly doubles the vehicle rate at every timepoint in both trials — a consistent, real, and very small effect.

| Item | Value (% ACHIEVING COMPOSITE SUCCESS) | Note |
| --- | --- | --- |
| HOUR 3 — DRUG / VEHICLE, TRIAL 1 | 12 | 12% against 6% on vehicle |
| HOUR 6 — DRUG, TRIAL 1 | 16 | Against 8% on vehicle — the peak |
| HOUR 9 — DRUG, TRIAL 1 | 18 | Against 6% on vehicle — the best result recorded |
| HOUR 12 — DRUG, TRIAL 1 | 15 | Against 6% on vehicle |
| HOUR 3 — DRUG, TRIAL 2 | 14 | Against 7% on vehicle |
| HOUR 6 — DRUG, TRIAL 2 | 13 | Against 5% on vehicle |
| HOUR 9 — DRUG, TRIAL 2 | 16 | Against 9% on vehicle |
| HOUR 12 — DRUG, TRIAL 2 | 12 | Against 6% on vehicle |

_Scale maximum: 20% ACHIEVING COMPOSITE SUCCESS._

> **THE NUMBER TO CARRY INTO THE APPOINTMENT** — At its best timepoint in its best trial, Rhofade produced a two-grade improvement on both scales in 18% of subjects. Vehicle produced it in 6%. Both figures are real and neither is a failure of the trial — this is simply what the drug does. Anyone considering it should decide in advance whether a roughly one-in-six chance of a clearly visible improvement, for part of a day, is worth what it costs. That is a legitimate decision to make. It is not the decision most people think they are making.

### The warnings narrow the market considerably

**WHO SHOULD NOT SIMPLY BE HANDED THIS**

| Field | Value |
| --- | --- |
| CARDIOVASCULAR | SEVERE, UNSTABLE OR UNCONTROLLED DISEASE; ORTHOSTATIC HYPOTENSION |
| BLOOD PRESSURE | UNCONTROLLED HYPERTENSION OR HYPOTENSION |
| VASCULAR INSUFFICIENCY | CEREBRAL OR CORONARY INSUFFICIENCY; RAYNAUD'S; THROMBOANGIITIS OBLITERANS |
| CONNECTIVE TISSUE | SCLERODERMA; SJÖGREN'S SYNDROME |
| EYE | NARROW-ANGLE GLAUCOMA — RISK OF ANGLE CLOSURE |

None of these is a contraindication; all are cautions. But look at the list against the population. Rosacea coexists with Raynaud's phenomenon and with connective tissue disease more often than chance, and a large share of this site's readers are at an age where blood pressure has become a live question. A vasoconstrictor applied daily to the face is not a cosmetic decision for someone in those groups, and the label says so clearly enough that a prescriber has no excuse for missing it.

### The one per cent that matters

Adverse reactions through four weeks were low: application site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%. Against vehicle those numbers are small and mostly unremarkable.

The one to notice is worsening inflammatory lesions. It affected seven of 489 treated subjects against one of 483 on vehicle. That is the specific concern people raise about vasoconstrictors in rosacea, and rather than being confined to anecdote it is quantified on the label. Seven in 489 is not a reason to avoid the drug. It is a reason to know what to watch for and to stop if you see it.

On rebound erythema more broadly, we will be precise rather than dramatic: the concern is well documented for brimonidine, the other approved treatment for rosacea erythema, and it is not established for oxymetazoline in these trials. Four hundred and forty subjects were followed for up to a year in an open-label extension. The label reports no rebound phenomenon and no guidance on discontinuation — which is an absence of evidence rather than evidence of absence, and worth raising with a prescriber before starting.

### If you are considering it

- Treat the inflammatory component first. R-40 and R-42 both do far more for papules and pustules than this does for redness.
- Check blood pressure, cardiovascular history, Raynaud's and glaucoma before starting. All three warning categories are on this label for a reason.
- Establish the price before filling it — the spread between discounted and average retail is roughly five-fold.
- Apply once daily in the morning, a pea-sized amount, avoiding the eyes.
- Set a review point. Four weeks is what the controlled trials ran; if it has done nothing visible by then, it is unlikely to start.
- Stop and seek advice if inflammatory lesions worsen.
- Ask specifically what the plan is if you want to stop, because the label has nothing to say about it.

### Where we stand

At 62 this is the lowest score we have given a manufactured, FDA-approved product, and the reason is not dishonesty — the disclosure here is excellent. It is that the disclosure is excellent and the result is poor. A demanding endpoint, honestly measured and honestly published, returned 12% to 18%.

That deserves to be said plainly, because facial redness is genuinely distressing and the market around it is full of confident claims. The approved, trialled, regulator-reviewed vasoconstrictor helps fewer than one user in five to the degree the trial called success. Anything promising more than that, at less than prescription strength and without a control arm, is not competing with this evidence. It is avoiding it.

**READ ALONGSIDE**

- [R-40 Galderma Soolantra](/reviews/soolantra-ivermectin-cream-review) — RECOMMENDED 82/100 — The drug for the other half of rosacea, with far stronger numbers.
- [R-42 LEO Pharma Finacea Foam](/reviews/finacea-foam-azelaic-acid-review) — RECOMMENDED 81/100 — Azelaic acid 15% foam — trialled in a population whose mean age was 50.6.

## Where to buy

| Retailer | Price | Link | Note | Commission-bearing |
| --- | --- | --- | --- | --- |
| Prescriber + retail pharmacy | from ~$150 | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34298db6-647d-480d-88a8-dc53258a5164 | Prescription only. Average retail near $864; discount-card prices start around $150. An authorised generic exists. | no |

We earn nothing on this link. Read the composite success figures before you fill this — 12% to 18% is the honest expectation, and the price varies by a factor of five.

**Also featured:** [CoreAge Rx skincare](https://try.coreagerx.com/skincare?utm_source=30plusskin&utm_medium=affiliate&utm_campaign=review&utm_content=rhofade-oxymetazoline-cream-review&utm_term=markdown) — Browse CoreAge Rx's prescription skincare range for concerns including fine lines, dark spots, blemishes and more.

## Sources

- [FDA-approved labelling — RHOFADE (oxymetazoline hydrochloride) cream, 1%, Mayne Pharma](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34298db6-647d-480d-88a8-dc53258a5164) — The 1% strength stated as 10 mg per gram with an 8.8 mg free-base equivalent; the two randomised vehicle-controlled trials in 885 subjects with the composite endpoint of at least a two-grade improvement on both CEA and SSA at hours 3, 6, 9 and 12 on day 29, and the results of 12–18% against 5–9%; the warnings on cardiovascular disease, potentiation of vascular insufficiency and angle closure glaucoma; the adverse reaction table including worsening inflammatory lesions of rosacea in 1%; and the open-label cohort of 440 subjects treated for up to one year. Read 2 August 2026.
- [GoodRx — Rhofade pricing](https://www.goodrx.com/rhofade) — Discount-card prices starting around $150 against an average retail price near $864. Retrieved 2 August 2026.

## Related records

- [R-40 Galderma Soolantra](/reviews/soolantra-ivermectin-cream-review) — RECOMMENDED
- [R-33 Alloy Rosacea Face Cream Rx](/reviews/alloy-rosacea-face-cream-review) — CONDITIONAL
- [L-04 The number nobody publishes](/ledger/the-number-nobody-publishes)
- [L-12 Rosacea prescriptions: persistent redness and bumps are different targets](/ledger/rosacea-prescriptions-redness-vs-bumps)
- [R-67 Strut Health Rosacea Formula](/reviews/strut-rosacea-formula-review) — CAUTION

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## Elsewhere in the register

- [Review register](/reviews)
- [Active monographs](/actives)
- [Brand register](/brands)
- [Evidence register](/evidence)
- [The ledger](/ledger)
- [How we test](/how-we-test)
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