Roflumilast Cream for Skin-Fold Psoriasis: What Did DERMIS Find?

A rash beneath a breast or along the groin needs a diagnosis before choosing a prescription cream. Bring the location, timing and previous treatment names to an examination. This article concerns confirmed plaque psoriasis.

What did the trials measure?

Two double-blind trials tested daily 0.3% cream for eight weeks. Prespecified secondary fold success meant clear/almost-clear with at least two grades of improvement, among those with initially mild-or-worse fold psoriasis.¹²

How many improved?

Week-eight FDA² estimates impute missing ratings, not responder counts. Both columns list cream/vehicle. Vehicle was the inactive cream base.²

Trial (eligible n)	Success
DERMIS-1 (63 / 32)	71.5% / 13.8%
DERMIS-2 (53 / 31)	67.5% / 17.4%

Adjusted advantages were 63.6 percentage points (95% confidence interval 43.7–83.4) and 52.7 points (30.9–74.5). Published observed rates differ.¹²

The fold test followed significant primary, time-to-50% PASI improvement and 75% PASI improvement results; PASI measures psoriasis severity. Arcutis funded the trials; authors disclosed company ties. Vehicle comparison cannot establish superiority to active treatments.¹²

Which cream does the current label cover?

The June 2026 US label covers 0.3% cream for plaque psoriasis, including folds, from age two. The 0.15% and 0.05% creams have eczema indications. Check the strength and diagnosis on the prescription.³

The cream is for skin, not eyes, mouth or inside the vagina.³

Moderate or severe liver impairment is a contraindication. Ask the pharmacist to review all medicines: certain enzyme inhibitors and a gestodene/ethinylestradiol contraceptive can increase exposure. Report diarrhea, headache, trouble sleeping, nausea or application-site pain.³

Discuss pregnancy and breastfeeding before treatment. Human pregnancy data are insufficient; the label advises avoiding use during labor and delivery. During breastfeeding, use the smallest area for the shortest duration, avoid the nipple and areola, and prevent infant contact with treated skin.³

What should you bring to the appointment?

Write down the exact location, sensation, onset and associated changes, including products or medicines started beforehand. Ask the clinician to name the condition and explain which skin can be treated. Bring the tube or a photograph of its strength label to follow-up.

“Describe It Before You Sort It” in Skin, Head to Toe helps organize those observations. The section supports describing a skin change for assessment; it does not identify the cause of a fold rash.