Double-blind, randomized comparative study of 2% topical formulations of ketoconazole and sertaconazole in the treatment of seborrheic dermatitis of the scalp

Kovalyova J.S., Kokina O.A., Vedler A.A., Karhova V.V., Makarenko E.S., Pisarev V.V., Merkulov M.E. , Sergeev A.Y.

Altai State Medical University, Institute of Public Health and Preventive Medicine, Barnaul, Russia
Psoriasis Center Barnaul, Barnaul, Russia
Regional Skin and Venereological Dispensary, Barnaul, Russia
Medical center Probiotech LLC, Moscow, Russia
Novosibirsk State University, Novosibirsk, Russia

Seborrheic dermatitis is a common chronic inflammatory skin condition. Antifungal medications remain as a mainstay of both topical and systemic therapy of the seborrheic dermatitis. Study purpose: To assess efficacy and safety of the new Russian-made formulation of 2 % sertaconazole medicinal shampoo (Sertaverine by Vertex JSC, Russia) in topical treatment of seborrheic dermatitis of the scalp compared with 2 % ketaconazole medicinal shampoo (Nizoral by Johnson & Johnson LLC).
Patients and methods: A randomized double-blind study with active control involved 188 adult patients of both sexes with seborrheic dermatitis of the scalp, accompanied by erythema, itching and desquamation. Patients were randomized in two comparable groups to receive either 2 % sertaconazole shampoo or 2 % ketoconazole shampoo, each medication being administered twice a week for 4 weeks. The efficacy of the therapy was evaluated at 4-weeks endpoint by changes in the disease severity score, global investigator’s and patient assessments and occurrence of adverse events were also tracked.
The results of this study demonstrate that the new 2 % sertaconazole medicinal shampoo produced in Russia by Vertex JSC, is not inferior in terms of effectiveness to the commonly used 2 % ketoconazole shampoo as the topical treatment of seborrheic dermatitis of the scalp. The primary and secondary endpoints of the study were reached with no statistically and clinically significant differences in safety and tolerability of medications between comparison groups.