- 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.
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).
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.