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Roflumilast foam led to high response rates in seborrheic dermatitis

Presented by
Prof. Andrew Blauvelt, Oregon Medical Research Center, OR, USA
EADV 2022
Phase 3, STRATUM

Roflumilast foam could offer a safe and effective treatment for seborrheic dermatitis. Over 80% of phase 3 study participants achieved clear or almost clear skin at week 8, while also experiencing a manifest improvement in manifests of erythema and scaling. At present, there are only limited options of on-label medications for people suffering from this disease.

Seborrheic dermatitis has a prevalence of around 5% worldwide [1,2]. “It’s a disease that is very common, yet in my opinion undertreated,” Prof. Andrew Blauvelt (Oregon Medical Research Center, OR, USA) stated [1]. Current therapy options include topical steroids and anti-fungals that may have some restrictions regarding side effects or difficulties in use in some body regions, especially the face and hair bearing areas.

Due to positive results in phase 2, a 0.3% foam preparation of the PDE4 inhibitor roflumilast was evaluated in the phase 3 STRATUM study (NCT04973228) on treatment for seborrheic dermatitis. After a 2:1 randomisation, participants received either the active drug foam once daily or a vehicle over 8 weeks. Recruited were 457 participants, among them 7% was between 9–17 years, as the disease already may occur in pubescents. The average age was 42, and there was an equal distribution of men and women.

All participants had an Investigator´s Global Assessment (IGA) ≥3, equalling at least moderate disease and an affected body surface area ≤20%. In practice, over 90% had an IGA of 3 at baseline and on average around 3% of the body surface was affected. 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 50% of the trial population.
Early onset of action

Statistical difference in favour of roflumilast already started at week 2. 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 moisturisation that the vehicle provided. 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 (see Figure) and 63.6% (P=0.0002) experienced a 4-point reduction on the worst-itch numeric rating scale.

Figure: Efficacy and safety of roflumilast foam 0.3% in seborrheic dermatitis [1]

The foams with roflumilast and the vehicle were both well tolerated throughout the trial with 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% on roflumilast versus 21.6% on 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
  2. Dessinioti C, et al. Clin Dermatol. 2013;31(4):343‒51.

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