Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color.

BACKGROUND

There is a paucity of data on usage of topical medications in patients with darker phototypes. This single-center, randomized, double-blinded, vehicle-controlled clinical study investigated the efficacy of a combination calcipotriene/betamethasone dipropionate (Cal/BD) aerosol foam 0.005%/0.064% in the treatment of psoriasis vulgaris in Fitzpatrick skin types IV to VI.

METHODS

25 adult subjects were randomized 4:1 to Cal/BD foam or foam vehicle once daily for 4 weeks followed by 4 weeks of open label treatment. From week 4 to week 8, subjects randomized to Cal/BD foam once daily switched to Cal/BD foam twice weekly for 4 weeks, while those randomized to vehicle applied Cal/BD foam once daily.

RESULTS

At week 4, 4/19 (21%) of Cal/BD foam patients achieved clear/almost clear Investigator Global Assessment (IGA) status with ≥2 grade improvement compared with 0/5 (0%) of vehicle patients (P=0.54). 12/19 (63%) of Cal/BD foam patients achieved a 50% reduction in Psoriasis Area and Severity Index (PASI 50) at week 4, compared with 0/5 (0%) of vehicle patients (P=0.04). Mean changes in melanin index at week 4 indicate a trend toward increased pigmentation in Cal/BD foam patients and decreased pigmentation in foam vehicle patients (P=0.30). All adverse events were mild and deemed unrelated to treatment by the investigators.

LIMITATIONS

The sample size was small and underpowered to detect statistically significant changes in most endpoints.

CONCLUSION

Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color. Larger studies involving skin of color populations with psoriasis are warranted. Pigmentary changes (hyper- and hypopigmentation) in lesional skin were observed. J Drugs Dermatol. 2023;22(2): 165-173.doi:10.36849/JDD.6910.