Using 0.03% Roflumilast Foam to Treat Plaque Psoriasis Affecting the Scalp
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on November 7th, 2025
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Treating plaque psoriasis affecting the scalp is challenging because the presence of hair can interfere with the application of topical agents in the form of ointment or cream. However, newer delivery methods such as foam might be more effective and suitable with hair care practice. With funding from Arcutis Biotherapeutics, a study was conducted to assess the usage of roflumilast foam to manage plaque psoriasis.
The study enrolled 432 participants diagnosed with plaque psoriasis involving both the scalp and body. Baseline assessment with the Investigator Global Assessment (IGA) scales showed that more than 85% of patients had moderate scalp psoriasis (IGA score 3), while the remainder had severe disease (IGA score 4). For body psoriasis, approximately 28% had mild disease (score 2), 66% had moderate disease (score 3), and the rest had severe disease (score 4).
The participants were randomly assigned to be treated with foam containing placebo or roflumilast at a concentration of 0.3%. Roflumilast functions as an inhibitor targeting phosphodiesterase 4, which will suppress the expression of key pro-inflammatory modulators such as IFN-gamma, TNF-alpha, IL-4, and IL-17. Additionally, inhibition of phosphodiesterase 4 can also increase the level of IL-10, which further suppresses inflammation and induces tissue repair.
After 8 weeks of treatment, the researchers found that the usage of foam containing 0.3% roflumilast was effective at treating plaque psoriasis on the scalp and body. Specifically, 66.4% of those treated with roflumilast had their IGA score for the scalp reduced to 0 or 1. This is signficantly more than the 27.8% success rate in the placebo group. Reduction in IGA score for body is less but still significant, with a success rate of 45.5% in those treated with roflumilast and 20.1% in the control group. The researchers noted that further studies should be conducted with a longer treatment duration and include more participants below 17 years old.
The study enrolled 432 participants diagnosed with plaque psoriasis involving both the scalp and body. Baseline assessment with the Investigator Global Assessment (IGA) scales showed that more than 85% of patients had moderate scalp psoriasis (IGA score 3), while the remainder had severe disease (IGA score 4). For body psoriasis, approximately 28% had mild disease (score 2), 66% had moderate disease (score 3), and the rest had severe disease (score 4).
The participants were randomly assigned to be treated with foam containing placebo or roflumilast at a concentration of 0.3%. Roflumilast functions as an inhibitor targeting phosphodiesterase 4, which will suppress the expression of key pro-inflammatory modulators such as IFN-gamma, TNF-alpha, IL-4, and IL-17. Additionally, inhibition of phosphodiesterase 4 can also increase the level of IL-10, which further suppresses inflammation and induces tissue repair.
After 8 weeks of treatment, the researchers found that the usage of foam containing 0.3% roflumilast was effective at treating plaque psoriasis on the scalp and body. Specifically, 66.4% of those treated with roflumilast had their IGA score for the scalp reduced to 0 or 1. This is signficantly more than the 27.8% success rate in the placebo group. Reduction in IGA score for body is less but still significant, with a success rate of 45.5% in those treated with roflumilast and 20.1% in the control group. The researchers noted that further studies should be conducted with a longer treatment duration and include more participants below 17 years old.