# R-55 — Allergan Aczone — Dapsone gel 5%

The one acne label in this register that publishes a sex difference — women responded better than men, and it says so. The local reactions are indistinguishable from the vehicle. The effect is the smallest here, and the price depends entirely on whether you ask for the generic.

- **Canonical:** https://www.30plusskin.care/reviews/aczone-dapsone-gel-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:** CONDITIONAL — Worth buying for a specific person with a specific problem. Read who.
- **Weighted score:** 71/100 across 75% of the scoring model
- **Score scope:** See assessed criteria
- **Category:** PRESCRIPTION MANUFACTURED / ACNE — ANTI-INFLAMMATORY SULFONE
- **Price:** $56 — PER TUBE · TWICE DAILY
- **Container size:** 30 G / 60 G TUBE
- **Prescription:** yes
- **Compounded:** no
- **Assessment basis:** DESK REVIEW
- **Last updated:** 2026-08-03
- **Manufacturer page:** https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7d605cf-bf84-461b-939b-1f773a4cba65

Dapsone is a sulfone with anti-inflammatory activity, and topically it is the gentlest thing in this register's acne section. Across four controlled trials in 1,819 treated subjects, the application-site reaction table is essentially the vehicle's: erythema mild in 9% against 9%, dryness mild in 14% against 14%, moderate reactions within a point or two either way. For someone whose skin has failed every retinoid and every benzoyl peroxide, that matters more than an effect size.

The effect size is the trade. Success on the Global Acne Assessment — no or minimal acne at twelve weeks — reached 42% and 35% against 32% and 28% on vehicle. Gaps of ten and seven points, the narrowest of any acne drug we have assessed. This is a real but modest drug, and the label's dosing section contains the appropriate response: if there is no improvement after twelve weeks, treatment should be reassessed.

One paragraph in the clinical studies section is the reason this review exists. 'Female subjects tended to have greater percent reductions in lesions and greater success on the Global Acne Assessment Score than males.' A sex difference in response, measured and published, on a label. Nothing else in this register does that — and for a site written mostly for women in their thirties and forties, it is the single most directly applicable sentence we have found on any acne label.

Two things to know before starting. Dapsone can cause methemoglobinemia, with hospitalisations reported postmarketing, and people with G6PD deficiency are more susceptible — the label names the ancestries in which that deficiency is most prevalent, which is more than most labels do with a population-specific risk. And the price runs from about $56 with a discount card to over $600 at retail, so this is a drug where asking about the generic changes the answer by an order of magnitude.

## Actives, as published

| Active | Concentration | Role | Benchmark | Assessment | Flagged |
| --- | --- | --- | --- | --- | --- |
| Dapsone | 5% | Sulfone with anti-inflammatory activity — inhibits neutrophil function and myeloperoxidase; the mechanism in acne is not fully established | 5% twice daily and 7.5% once daily are the approved topical strengths | An old systemic drug repurposed topically, at a concentration that produces almost no local reaction and a modest effect. Its distinguishing feature is not potency — it is that it does not behave like the rest of the category, which is precisely why it is worth having for people the rest of the category has defeated. | no |

## Scoring

| Criterion | Weight | Score | Note |
| --- | --- | --- | --- |
| EVIDENCE FOR THE ACTIVE | 30% | 70/100 | Two randomised double-blind vehicle-controlled trials in 3,000 subjects, with the five-point assessment scale printed, lesion reductions reported separately, a published sex-difference finding and a racial breakdown with subgroup results. Marked down because the effect is the smallest of any acne drug here — ten and seven points over vehicle — and because both trials excluded subjects who were already minimal at baseline. |
| FORMULATION INTEGRITY | 20% | 66/100 | A gel at the trialled strength, two tube sizes published, full excipient list, and a local reaction profile matching its own vehicle. Marked down because the label itself concedes the product is 'gritty with visible drug substance particles' — honest, and a genuine cosmetic drawback for a leave-on facial gel used twice daily — and because twice-daily dosing is harder to sustain than the newer 7.5% once-daily version. |
| DISCLOSURE | 15% | 88/100 | Publishes a sex difference in response, the full assessment scale, the racial composition with a statement that results were similar across subgroups, application-site reactions graded by severity against vehicle, a methemoglobinaemia warning with the ancestries most affected by G6PD deficiency named, and a twelve-week futility rule in the dosing section. Held back only because the sex-difference finding is stated qualitatively without numbers. |
| TOLERANCE IN USE | 15% | not scorable | Not assessed by us, and the label's table is the product's whole argument: mild erythema 9% against 9% on vehicle, mild dryness 14% against 14%. A panel would establish whether the grittiness is a practical problem in daily use, which no label can answer. |
| TEXTURE & WEAR | 10% | not scorable | Not assessed, and it is unusually relevant here — a gel described by its own manufacturer as gritty with visible particles, worn twice daily under whatever else you use. |
| COST PER APPLICATION | 10% | 62/100 | Generic dapsone gel from around $56 with a discount card against brand retail of $527 to $692 depending on size and strength — roughly a tenfold spread on the same molecule. Both tube sizes are published so cost per gram is computable. Good value bought carefully, poor value bought carelessly. |

_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

- Publishes a sex difference in response — women did better, and the label says so.
- Local application-site reactions are indistinguishable from the vehicle arm.
- Reports reactions graded by severity against vehicle, not as a single rate.
- Prints the full five-point Global Acne Assessment scale, so 'success' is checkable.
- Publishes the racial composition of the trials and states results were similar across subgroups.
- Names the ancestries in which G6PD deficiency is most prevalent, rather than mentioning the deficiency abstractly.
- Carries a twelve-week futility rule in the dosing section: if there is no improvement, reassess.
- Concedes in its own dosing instructions that the gel is gritty with visible drug particles.
- No contraindications listed.
- Both tube sizes published; a cheap generic exists.
- A mechanism unlike anything else in the acne section, which is the reason to reach for it.

## Weaknesses

- The smallest effect of any acne drug in this register: ten and seven points over vehicle.
- Twice-daily dosing for the 5% gel.
- Gritty texture with visible particles, on the face, twice a day.
- Methemoglobinaemia has been reported postmarketing, with hospitalisation.
- People with G6PD deficiency developed laboratory changes suggestive of haemolysis.
- The sex-difference finding is published qualitatively, with no numbers attached.
- The trials excluded subjects already at minimal acne, which flatters the success denominator.
- Brand retail runs to $692, and nothing about the molecule justifies it.

## Suits

- Someone whose skin has not tolerated retinoids or benzoyl peroxide — this is the gentlest option in the acne section by a wide margin.
- A woman with adult acne, given that the trials found greater response in female subjects and said so.
- Someone who wants to combine an anti-inflammatory with a retinoid without stacking two irritants.
- Someone who will ask for the generic, which changes the price by roughly tenfold.

## Avoid if

- You have G6PD deficiency, or congenital or idiopathic methemoglobinaemia.
- You are taking other methemoglobin-inducing drugs.
- You need a large effect quickly — this is the most modest acne drug here.
- A gritty leave-on gel twice daily is not something you will keep doing.
- You are paying brand retail without having asked about the generic.

## The full assessment

### What it is

Dapsone 5% in a gel, applied twice daily, approved for acne vulgaris. Thirty and sixty gram tubes. Generic dapsone gel is available from around $56 with a discount card; the brand runs several hundred dollars. A once-daily 7.5% version also exists.

**RECORD**

| Field | Value |
| --- | --- |
| BRAND | ALLERGAN |
| PRODUCT | ACZONE (DAPSONE) GEL, 5% |
| ACTIVE | DAPSONE 50 MG PER GRAM |
| CLASS | SULFONE — ANTI-INFLAMMATORY |
| DOSING | TWICE DAILY |
| CONTRAINDICATIONS | NONE LISTED |
| TRIAL DURATION | 12 WEEKS · 2 TRIALS · N=3,000 |
| SAFETY POPULATION | 1,819 TREATED SUBJECTS |
| FUTILITY RULE | REASSESS IF NO IMPROVEMENT AT 12 WEEKS |
| SIZES | 30 G AND 60 G |
| PRICE | GENERIC FROM ~$56 · BRAND $527–$692 |

### The sentence no other acne label contains

> Female subjects tended to have greater percent reductions in lesions and greater success on the Global Acne Assessment Score than males.

> — FDA-approved labelling, Clinical Studies

> **A SEX DIFFERENCE, MEASURED AND PUBLISHED** — L-10 argued that the useful follow-up to 'clinically proven' is 'proven in whom', and that the demographic tables behind these products rarely describe the people buying them. This label goes one step further than any other here: it does not merely report who was enrolled, it reports that the drug worked differently in half of them. For a readership of women with adult acne, that is more decision-relevant than the effect size — and it is one sentence, with no numbers attached, which is the only thing wrong with it.

The racial breakdown is handled the same way: 73% Caucasian, 14% Black, 9% Hispanic, 2% Asian, with an explicit statement that efficacy results were similar across the racial subgroups. Set that against Soolantra's 96% Caucasian and Mirvaso's 99%, where the composition is printed and nothing is said about what it means.

### The gentlest thing in the acne section

**FIG. 1 — APPLICATION-SITE REACTIONS BY SEVERITY, 12 WEEKS** — Aczone N=1,819, vehicle N=1,660, pooled across four controlled trials. Bars show mild reactions; the notes carry the moderate and severe splits. The drug arm and the vehicle arm are the same table.

| Item | Value (% OF SUBJECTS — MILD) | Note |
| --- | --- | --- |
| ERYTHEMA — ACZONE | 9 | Mild 9%, moderate 5%, severe <1% |
| ERYTHEMA — VEHICLE | 9 | Mild 9%, moderate 6%, severe <1% |
| DRYNESS — ACZONE | 14 | Mild 14%, moderate 3%, severe <1% |
| DRYNESS — VEHICLE | 14 | Mild 14%, moderate 4%, severe <1% |

_Scale maximum: 16% OF SUBJECTS — MILD._

On moderate erythema and moderate dryness the vehicle scored worse than the drug. This is the second product in this register — after Winlevi at R-39 — whose local reaction table is indistinguishable from its own base, and both belong in the same conversation: what do you give someone whose skin has defeated every conventional option?

### And the smallest effect

**FIG. 2 — SUCCESS AT WEEK 12: NO OR MINIMAL ACNE** — Study 1: N=699 against 687. Study 2: N=729 against 738. Both analyses exclude subjects classified as minimal at baseline. Gaps of ten and seven points — the narrowest for any acne product in this register.

| Item | Value (% SUCCESS) | Note |
| --- | --- | --- |
| ACZONE — STUDY 1 | 42 | 291 of 699 subjects |
| VEHICLE — STUDY 1 | 32 | 223 of 687 — the highest vehicle response in the acne section |
| ACZONE — STUDY 2 | 35 | 253 of 729 |
| VEHICLE — STUDY 2 | 28 | 206 of 738 |

_Scale maximum: 45% SUCCESS._

Those vehicle arms are worth noting on their own. A third of subjects applying a gel base twice daily for twelve weeks reached no or minimal acne. L-08 made the general point; this is one of its clearest instances, and it is why the drug's ten-point advantage is the honest size of what dapsone adds.

The label responds to its own modest effect appropriately. The dosing section instructs that if there is no improvement after twelve weeks, treatment should be reassessed. That is a futility rule — a stated point at which continuing is not the default — and it is the third one in this register after Obagi's and Seysara's.

### The two things to check first

- Methemoglobinaemia has been reported postmarketing in association with this gel, with resultant hospitalisation. Early signs are a slate-grey cyanosis at the lips, nail beds and inside the mouth, and they can appear some hours after exposure. If that happens, stop and seek medical attention.
- People with G6PD deficiency are more susceptible, and some developed laboratory changes suggestive of haemolysis. The label states that G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern and Mediterranean ancestry — a population-specific risk named rather than left abstract.
- Avoid it entirely in congenital or idiopathic methemoglobinaemia.
- Dapsone can raise methemoglobin levels particularly alongside other methemoglobin-inducing agents, so the full medication list matters here more than usual.

### If you are considering it

- Ask for generic dapsone gel. The spread against brand retail is roughly tenfold on the same molecule.
- Ask about the 7.5% once-daily version if twice-daily dosing is the obstacle.
- Mention G6PD deficiency if you know of it in yourself or your family, and mention any other medication.
- A pea-sized amount, rubbed in completely, twice daily on washed and dried skin.
- Expect grittiness — the label says so, and it is a gel you leave on.
- Give it twelve weeks, then honour the label's own instruction and reassess rather than continuing by default.
- Consider it as a partner to a retinoid rather than a replacement, since the mechanisms do not overlap and this one adds almost no irritation.

### Where we stand

At 71 this is a modest drug with an unusually thoughtful label. The effect is the smallest in the acne section, the texture is conceded to be gritty, and the brand price is indefensible — but the tolerability is genuinely exceptional, and the disclosure does two things almost nothing else here manages: it publishes a sex difference in response, and it names the populations a specific risk falls on.

That combination makes it a specific rather than a general recommendation. If retinoids and benzoyl peroxide have already failed on tolerability grounds, this is the drug to ask about, and the fact that the trials found women responding better than men is a reason for this readership to ask sooner rather than later.

**READ ALONGSIDE**

- [R-39 Sun Pharmaceutical Winlevi](/reviews/winlevi-clascoterone-cream-review) — CONDITIONAL 72/100 — The other acne drug whose local reactions match its own vehicle.
- [L-10 Proven in whom](/ledger/proven-in-whom) — Demographic tables, and the one label that reports a difference rather than just a composition.
- [L-08 Ask what the vehicle arm did](/ledger/ask-what-the-vehicle-arm-did) — A third of subjects reached no or minimal acne on the gel base alone.

## Where to buy

| Retailer | Price | Link | Note | Commission-bearing |
| --- | --- | --- | --- | --- |
| Prescriber + retail pharmacy | from ~$56 | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7d605cf-bf84-461b-939b-1f773a4cba65 | Prescription only. Generic dapsone gel from around $56 with a discount card; brand retail runs $527 to $692 depending on size and strength. | no |

We earn nothing on this link. Ask for generic dapsone gel and ask about the once-daily 7.5% strength — the brand-to-generic spread here is roughly tenfold.

**Featured alternative:** [CoreAge Rx Pore Favor](https://www.coreagerx.com/product/pore-favor/?utm_source=30plusskin&utm_medium=affiliate&utm_campaign=review&utm_content=aczone-dapsone-gel-review&utm_term=markdown) — Salicylic acid, zinc oxide, niacinamide and urea for blemishes and congestion. From $42 / month advertised.

## Sources

- [FDA-approved labelling — ACZONE (dapsone) Gel, 5%, Allergan, Inc.](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7d605cf-bf84-461b-939b-1f773a4cba65) — The 5% strength stated as 50 mg per gram in 30 g and 60 g tubes; twice-daily dosing with the instruction to reassess if there is no improvement after 12 weeks and the statement that the gel is gritty with visible drug substance particles; the absence of listed contraindications; the methemoglobinaemia warning including postmarketing hospitalisations and the G6PD susceptibility with the affected ancestries named; the application-site adverse reaction table by severity in 1,819 treated subjects against 1,660 on vehicle; the two vehicle-controlled trials (N=1,475 and 1,525) with Global Acne Assessment success of 42% against 32% and 35% against 28%; the printed five-point assessment scale; the statement that female subjects tended to have greater lesion reductions and greater success than males; and the racial composition of 73% Caucasian, 14% Black, 9% Hispanic and 2% Asian with similar results across subgroups. Read 3 August 2026.
- [GoodRx — Aczone and generic dapsone gel pricing](https://www.goodrx.com/aczone) — Brand tube prices of $527.03 for 60 g of 5% and $691.29 for 90 g, against generic dapsone gel from around $55.93 with a discount card. Retrieved 3 August 2026.

## Related records

- [R-39 Sun Pharmaceutical Winlevi](/reviews/winlevi-clascoterone-cream-review) — CONDITIONAL
- [L-10 Proven in whom](/ledger/proven-in-whom)
- [L-08 Ask what the vehicle arm did](/ledger/ask-what-the-vehicle-arm-did)

---

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---

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- [Review register](/reviews)
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