LEO Pharma
One product, and it was the first registration programme in this register enrolled in the population this site is written for — mean age 50.6, range 19 to 92. It is also the cheapest prescription we have assessed.
MODEL
New Drug Application, manufactured product, retail pharmacy dispensing on a prescriber's script.
The brand verdict
One product assessed. Finacea Foam is azelaic acid 15% in a hydrophilic foam for the papules and pustules of rosacea, and its distinguishing feature in this register is demographic rather than pharmacological: 1,362 subjects aged 19 to 92, mean age 50.6, 73.4% female. Every other registration programme here was run in acne populations with a mean age around twenty.
The efficacy is solid and modestly reported. Investigator global assessment success reached 32.1% and 43.4% against 23.4% and 32.5% on vehicle — gaps of roughly nine and eleven points, with high vehicle responses that the label makes no attempt to minimise. Inflammatory lesions fell by about thirteen from a mean baseline of 21.3.
The vehicle arms are worth as much as the drug arms. Trial subjects were instructed to avoid their own flushing triggers and to stop using soaps, astringents, tinctures and abrasives. A meaningful share of what the vehicle group achieved was trigger avoidance and irritant removal — which is real treatment that costs nothing and that no product page will sell you.
Three warnings are stated specifically and one of them matters. Azelaic acid inhibits tyrosinase, which is why it works on pigment and why hypopigmentation has been reported; the label instructs monitoring in patients with dark complexions and concedes the drug has not been well studied in them. The propellant is flammable. And azelaic acid irritates the eyes. All three are the kind of practical warning a compounded equivalent has no mechanism to deliver.
- A trial population with a mean age of 50.6 and a range of 19 to 92.
- 1,362 subjects across two vehicle-controlled 12-week trials.
- Full IGA scale definitions published, so 'success' is checkable.
- Both trials reported, including the weaker one.
- Complete exclusion criteria published, including ocular, phymatous and plaque-type rosacea.
- The trigger and irritant avoidance instructions given to subjects are published, so the vehicle arm can be understood.
- Hypopigmentation disclosed with a specific instruction to monitor darker complexions.
- Eye irritation and propellant flammability both stated plainly.
- Concentration, fill weight and excipients all published.
The range
- R-422026-08-02
Finacea Foam
AZELAIC ACID 15% FOAMThe only registration programme in this entire register whose subjects had a mean age of 50.6 — which is to say, the only trial population that looks like the people this site is written for. It also happens to be the cheapest prescription in the register.
RECOMMENDED$36 PER 50 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
The only trial population that matches the readership
Mean age 50.6, range 19 to 92. Against acne programmes with mean ages around twenty and 42% to 45% of subjects under eighteen. Almost everything a fifty-year-old is prescribed for their skin was trialled on people half their age, and the extrapolation is so routine nobody names it.
- 02
The vehicle arm is part of the finding
23.4% and 32.5% of subjects succeeded on foam base plus instructions. The instructions were trigger avoidance and stopping irritants. That is a substantial share of the total benefit, available free, and it is the single most actionable thing on the label.
- 03
The pigment warning names who it falls on
Hypopigmentation has been reported; azelaic acid has not been well studied in patients with dark complexion; monitor those patients for early signs. The mechanism that treats pigmentation is the mechanism that can remove it where you did not intend, and the label says so rather than leaving it to be discovered.
- 04
Fifteen per cent is where the evidence lives
This register has found azelaic acid compounded at 17%, 10%, 6% and 4%. The approved rosacea strength is 15% and the approved acne strength is 20%, and both come from trial programmes. Every other figure is an assumption about a dose-response curve nobody has drawn.
- 05
The cheapest prescription in the register
From around $36 with a discount card against an average retail near $261, with generic azelaic acid 15% widely available and the fill weight published. It is not the most effective rosacea treatment here, but it is the best value by a wide margin.
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 |
|---|---|---|---|---|---|
| Finacea Foam | YES | YES | YES | YES | YES |
If you buy one
Finacea Foam
Buy it. The formula, the disclosure and the price all hold up.
Finacea Foam
Buy it. The formula, the disclosure and the price all hold up.