# A-09 — Roflumilast

The highest response rates in this register, the cleanest tolerability in it, and the worst price in it. All three at once.

- **Canonical:** https://www.30plusskin.care/actives/roflumilast
- **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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## Datasheet

- **INN / INCI:** Roflumilast
- **Family:** Phosphodiesterase-4 inhibitor
- **Molecular weight:** 403.21 g/mol
- **Layer reached:** EPIDERMIS
- **Prescription only:** yes
- **Evidence grade:** A
- **Controlled trials on file:** 2
- **Strength range recorded:** 0.15%–0.3%
- **Representative reference concentration:** 0.3%
- **Irritation (0–10):** 1
- **Onset:** 8 WK
- **Stability:** ROOM TEMPERATURE · FLAMMABLE PROPELLANT

## Mechanism

The concentration marker is not a recommended dose or a claim that other strengths are untested. Compare the vehicle, indication and trial population.

Inhibits PDE4, raising intracellular cyclic AMP and suppressing the inflammatory cytokine cascade. Because it acts through no corticosteroid receptor, it carries none of the atrophy or telangiectasia constraints that limit facial steroid use.

## Measured endpoints

| Endpoint | Effect vs comparator | Window | Record |
| --- | --- | --- | --- |
| IGA success, seborrhoeic dermatitis | +21.5% | 8 WK | REF-20 — Zoryve foam — trial STRATUM (NCT04973228), seborrhoeic dermatitis (Randomised 2:1, vehicle-controlled; treatment difference 20.6% (95% CI 11.2–30.0), n=457, grade A) |
| Scalp IGA success, psoriasis | +38.6% | 8 WK | REF-21 — Zoryve foam — trial ARRECTOR (NCT05028582), scalp psoriasis (Randomised 2:1, vehicle-controlled; treatment difference 37.1% (95% CI 27.1–47.1), n=432, grade A) |

## Layering

- **Do not layer with:** Moderate to severe liver impairment — contraindicated, Fire, flame and smoking during application
- **Pairs with:** Antifungal shampoo, A bland moisturiser

## Notes

- Applied daily to inflamed facial skin and scalp for eight weeks across 458 subjects, no local skin reaction reached 1%. What appears instead — nausea, headache, diarrhoea — is the systemic signature of PDE4 inhibition.
- The seborrhoeic dermatitis vehicle arm reached 58%, the highest in this register. A bland foam applied consistently does a great deal.
- Steroid-free matters here: seborrhoeic dermatitis is lifelong and relapsing, and a facial corticosteroid cannot be used that way.
- 408 subjects continued for 24 to 52 weeks with a consistent profile — one of only two molecules here with year-scale data.

## Products in the register containing it

| No. | Product | Stance | Score | Document |
| --- | --- | --- | --- | --- |
| R-49 | Arcutis Zoryve Foam | CONDITIONAL | 78/100 | /reviews/zoryve-foam-roflumilast-review |

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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)
- [Agent guide](/llms.txt)
- [Sitemap](/sitemap.xml)

_SOURCE-BASED ASSESSMENTS. PUBLISHER PREFERENCES ARE IDENTIFIED SEPARATELY._