Galderma / Soolantra
IVERMECTIN CREAM 1%
Two trials, 1,371 subjects, a 65% reduction in inflammatory lesions and roughly two in five reaching clear or almost clear — and a safety database of 519 people who used it for a year. It is the best-evidenced single topical for papulopustular rosacea, and the reference the compounded versions are quietly diluting.
Buy it. The formula, the disclosure and the price all hold up.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. Ask whether generic ivermectin cream 1% is available to you — it is the same strength, and the price gap is large.
The verdict
This is the strongest evidence for any single topical in the register. Two identically designed vehicle-controlled trials in 1,371 adults, twelve weeks, with co-primary endpoints agreed in advance: investigator global assessment of clear or almost clear, and absolute change in inflammatory lesion count. Both were met in both trials, and the separation from vehicle began at week four.
The numbers hold up under inspection. Clear or almost clear was reached by 38.4% and 40.1% of subjects, against 11.6% and 18.8% on vehicle. Inflammatory lesions fell by 20.5 and 22.2 on average — reductions of 64.9% and 65.7% — against 41.6% and 43.4% on vehicle. A two-thirds reduction in papules and pustules is a result patients notice in the mirror, not merely on a lesion count sheet.
The safety base is the part most compounded rosacea products cannot approach. Two thousand and forty-seven subjects received the drug in the trial programme, 1,555 of them for more than twelve weeks, and 519 for approximately one year. Adverse reactions occurring in 1% or fewer were skin burning and skin irritation. On skin that is intolerant by definition, that is the number that decides whether a treatment is usable.
The reason to read this review alongside R-33 is arithmetic. Ivermectin was approved at 1% because 1% is what these trials tested. When a compounded rosacea cream contains ivermectin at 0.88%, it is delivering 88% of the strength that produced these figures, and no trial anywhere tells you what the other 12% was worth. This is what the reference product looks like — and reference products are the reason we can even ask that question.
- The largest and cleanest evidence base for any single topical in this register.
- Co-primary endpoints prespecified and both met in both trials.
- Inflammatory lesion reductions of about 65%, against about 42% on vehicle.
- Separation from vehicle visible by week four.
- 519 subjects treated for approximately one year — real long-term safety data.
- Adverse reactions at 1% or below, on a population defined by skin intolerance.
- Once daily.
- Three tube sizes published, so cost per gram is computable.
- A generic exists at the same strength.
- Baseline severity distribution published: 79% moderate, 21% severe.
- 96% of trial subjects were Caucasian, in a condition whose presentation and diagnosis differ markedly in darker skin.
- Treats inflammatory lesions only — nothing here addresses persistent erythema or telangiectasia.
- No head-to-head data on the label against metronidazole or azelaic acid, the other first-line options.
- Average retail pricing is high relative to the generic.
- Adverse reactions are reported only as a category, without a rate table against vehicle.
- No guidance on trigger avoidance, which is a substantial part of rosacea management.
- Nothing on the label about how long treatment should continue or when to stop.
Every active, assessed
- Ivermectin1%
Antiparasitic and anti-inflammatory — reduces Demodex density and moderates the inflammatory response to it
- BENCHMARK
- 1% is the approved and trialled concentration; there is no other
- ASSESSMENT
- The single most effective topical agent in papulopustular rosacea on head-to-head evidence, at the concentration the evidence was generated at. Once daily, in a cream, with a year of continuous-use safety data behind it. Everything a compounded rosacea formula claims to improve on, this establishes the baseline for.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| IvermectinAntiparasitic and anti-inflammatory — reduces Demodex density and moderates the inflammatory response to it | 1% | 1% is the approved and trialled concentration; there is no other | The single most effective topical agent in papulopustular rosacea on head-to-head evidence, at the concentration the evidence was generated at. Once daily, in a cream, with a year of continuous-use safety data behind it. Everything a compounded rosacea formula claims to improve on, this establishes the baseline for. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%86/100
Two identical vehicle-controlled trials, 1,371 subjects, co-primary endpoints both met in both trials, separation from week four, and a long-term safety cohort of 519 subjects at one year. The best evidence base for a single agent in this register. Marked down because 96% of subjects were Caucasian and because the trials excluded the erythema and telangiectasia components that many patients most want treated.
- FORMULATION INTEGRITYWEIGHT 20%80/100
A straightforward once-daily cream at the trialled strength, in three published tube sizes, manufactured to pharmaceutical standard with a full excipient list. Nothing clever, and nothing needed to be. Marked down only relative to products where the vehicle is itself part of the therapeutic design.
- DISCLOSUREWEIGHT 15%88/100
Concentration in per cent and milligrams per gram, three fill weights, full excipients, both trials with vehicle arms, baseline severity distribution, the long-term safety cohort with its size and duration, and adverse reactions quantified. Held back because the trial population's ethnic composition is stated but its implications are not, and because nothing on the label addresses the erythema most rosacea patients also have.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed by us, though the label reports adverse reactions at 1% or below — burning and irritation — across a cohort including 519 people at one year. That is the most reassuring tolerability signal in the register and a panel would mostly be confirming it.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. Applied once daily at bedtime, so daytime wear is not the issue it would be for a morning product.
- COST PER APPLICATIONWEIGHT 10%62/100
Average retail around $336, with discount-card prices starting near $100 and a generic available. Three fill weights are published so cost per gram is computable at each. Reasonable for twelve weeks of a drug with this evidence base, expensive if bought at brand retail without checking the generic.
What it is
Ivermectin 1% in a cream, applied once daily at bedtime, approved for the inflammatory lesions of rosacea. Tubes of 30 g, 45 g and 60 g. It is the single best-evidenced topical in this register, and the origin point for the ivermectin that appears, diluted, in compounded rosacea formulas.
The co-primary endpoints, both met, twice
Both trials prespecified two primary endpoints and had to satisfy both: the proportion of subjects rated clear or almost clear on a five-point investigator global assessment, and the absolute change in inflammatory lesion count. Prespecifying two endpoints and hitting both is a harder test than reporting whichever measure came out best, and it is the design difference that separates a registration programme from a satisfaction survey.
Study 1: N=451 against 232 on vehicle. Study 2: N=459 against 229. At baseline 79% of subjects were rated moderate and 21% severe. The vehicle arms differ from each other by seven points, which is the ordinary noise of a rosacea trial and the reason two trials are required.
On the second endpoint, inflammatory lesions fell by 20.5 and 22.2 in absolute terms — 64.9% and 65.7% of baseline — against 12.0 and 13.4 on vehicle, or 41.6% and 43.4%. Note how much the vehicle arms achieved: applying a bland cream nightly and being enrolled in a trial removed about four in ten lesions. The drug's contribution is the extra quarter, and it is a large, consistent, prespecified quarter.
The year of data
Two thousand and forty-seven subjects received Soolantra during the programme. One thousand five hundred and fifty-five used it for more than twelve weeks. Five hundred and nineteen used it for approximately one year. Adverse reactions reported in 1% or fewer of subjects treated for at least three months in vehicle-controlled trials were skin burning sensation and skin irritation.
Rosacea is not an eight-week problem. Anyone who responds to a topical will be asked to keep using it, and the question that actually matters is what a year of nightly application does. This label answers it with a cohort size and a duration. Every compounded rosacea product in this register is sold on open-ended monthly billing with no long-term data of any kind — the subscription assumes indefinite use, and only the manufactured product has studied it.
What it does not treat
The indication is the inflammatory lesions of rosacea: papules and pustules. It is not persistent facial erythema, not flushing, and not telangiectasia. Many people with rosacea have both components, and clearing the bumps while the redness remains is a partial result that the label is careful not to overstate — R-41 is the drug approved for the other half, and its numbers are far weaker.
The other limitation is the trial population: 96% Caucasian, 67% female. Rosacea in skin of colour is under-diagnosed and presents differently, and a programme of this size that enrolled almost no one with darker skin leaves a real gap. The label states the composition; it does not draw the conclusion.
The dilution question
Ivermectin's approved strength is 1% because 1% is what produced the figures above. This register has already found it compounded at 0.88% in a three-active rosacea cream at R-33, and blended into multi-agent formulas elsewhere.
There is nothing dishonest about that — combining agents necessarily dilutes each of them, and the company that did it published its numbers. The point is narrower and it applies to every compounded formula in this register: once a concentration departs from the trialled one, the trial no longer tells you what happens. You are relying on the assumption that the dose-response curve is flat over that interval. Sometimes it is. Nobody has measured it here.
If you are considering it
- Ask whether generic ivermectin 1% cream is available to you before filling the brand.
- Once daily at bedtime, a pea-sized amount for the whole face.
- Give it twelve weeks, but expect to see movement by week four — that is when the trials separated.
- If your main complaint is redness rather than bumps, this is the wrong drug and R-41 is the one to discuss.
- Ask what the plan is beyond twelve weeks. The label supports a year of use; it does not tell you when to stop.
- Do the trigger work — heat, alcohol, spice, sun, stress. No topical substitutes for it.
- Wear sunscreen. Ultraviolet is among the most consistent rosacea triggers and no rosacea label makes enough of that.
Where we stand
At 82 this is one of the highest scores we have given, and it is earned by ordinary competence rather than novelty: a well-designed programme, two consistent trials, prespecified endpoints, a real long-term cohort, a published tolerability profile and three fill weights on the carton.
It also does something for the rest of this register. Every compounded rosacea formula we have reviewed is an arrangement of agents whose individual evidence comes from programmes like this one. When those agents are recombined at new strengths and sold monthly, the evidence does not travel with them. Soolantra is where the evidence actually lives.
The compounded version, with ivermectin at 0.88% and no trial of the combination.
The other compounded rosacea service in the register.
The drug approved for the redness this one does not treat.
Who this is for
- Someone with papulopustular rosacea who wants the best-evidenced single topical available.
- Someone who has found metronidazole or azelaic acid insufficient.
- Someone whose skin will not tolerate an aggressive regimen — the reaction rates here are the lowest in the register.
- Someone weighing a compounded rosacea combination and wanting the benchmark it is being blended down from.
- Someone who needs a treatment with a genuine one-year safety cohort behind it.
- Your rosacea is mainly flushing and visible vessels — this treats papules and pustules and nothing else.
- You want evidence generated in skin of colour, which this programme largely does not provide.
- You are pregnant or breastfeeding and want firm guidance; discuss it, because the label's position is limited.
- You are buying brand at retail without first asking about the generic.
We earn nothing on this link. Ask whether generic ivermectin cream 1% is available to you — it is the same strength, and the price gap is large.
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 — SOOLANTRA (ivermectin) cream, 1%, Galderma Laboratories, L.P. The 1% strength stated as 10 mg per gram and the 30 g, 45 g and 60 g tube sizes; the two 12-week vehicle-controlled trials in 1,371 subjects with IGA success of 38.4% against 11.6% and 40.1% against 18.8%; inflammatory lesion reductions of 20.5 (64.9%) and 22.2 (65.7%) against 12.0 (41.6%) and 13.4 (43.4%); separation from vehicle at week four; the baseline severity split of 79% moderate and 21% severe; the demographic composition of 96% Caucasian and 67% female; and the safety cohort of 2,047 subjects including 1,555 beyond 12 weeks and 519 at approximately one year, with adverse reactions at 1% or below. Read 2 August 2026.
- S-02GoodRx — Soolantra pricing Discount-card prices starting near $99.67 against an average retail price around $335.54. Retrieved 2 August 2026.