Roflumilast 0.3% foam beneficial in various aspects of seborrheic dermatitis

A new study shows over 80% of primary endpoint reach of clear or almost clear skin, according to the Investigator's Global Assessment at week 8.

Most common body regions involved were scalp, face, and ears

Due to positive results in phase 2, a 0.3% foam preparation of the PDE4-inhibitor roflumilast entered phase 3 in the STRATUM study (NCT04973228) on treatment for seborrheic dermatitis. After a 2:1 randomisation, patients received either the active drug foam once daily or a vehicle over 8 weeks. 457 participants were recruited, among them 7% aged 9–17, as the disease already may occur in pubescents.

Participants all had IGA ≥3, equalling at least moderate disease and an affected body surface area ≤20%. Success, in terms of the primary endpoint, meant achieving an IGA of 0/1 corresponding to clear or almost clear skin. The most common body regions involved were: scalp in around 90%, face in over 60%, and ears in more or less than 50% of the trial population. “The average age was 42, it was half men and half women in this trial,” Prof. Andrew Blauvelt (Oregon Medical Research Center, OR, USA) described. Over 90% had an IGA of 3 at baseline and on average around 3% of the body surface was affected.

Statistical difference in favour of roflumilast already started at week 2 and at week 8, 80.1% of participants attained success with an IGA of 0/1 on roflumilast in comparison with 59.2% on placebo (P<0.0001).

High placebo rate may be due to once-daily moisturising vehicle used

Prof. Blauvelt attributed the high placebo rate to the possibility of a beneficial effect through the once-daily moisturising that the vehicle provided.

Worth mentioning is also that over half of the participants were completely clear of disease after 8 weeks (50.7%; P<0.0001). Furthermore, 57.9% (P<0.0001) and 58.2% (P<0.0001) achieved scores of 0 for erythema and scaling at week 8 and 63.6% (P=0.0002) experienced a 4-point reduction on the worst-itch numeric rating scale.

The foams with roflumilast and the vehicle were both well tolerated throughout the trial with e.g. 97.8% and 94.8% of participants reporting no or only mildly discomforting sensation at week 8. The safety profile did not raise concerns: any treatment-emergent events appeared in 23% versus 21.6% on roflumilast versus placebo.

“Many patients responded in this trial; so much so that I called it the “happy trial”. Every time I saw patients in this trial, they seemed to be happy,” Prof. Blauvelt remarked in view of the results.

  1. Blauvelt A. Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a phase 3 trial. D2T01.3F, EADV Congress 2022, Milan, Italy, 7-10. September.