A Comparative Randomized Clinical Study Assessing the Efficacy of a 1% Selenium Disulfide-Based Shampoo versus 2% Ketoconazole Shampoo in Subjects with Moderate to Severe Scalp Seborrheic Dermatitis.

Introduction: Scalp seborrheic dermatitis (SSD) is a chronic, relapsing, and inflammatory condition impacting quality of life (QoL). This study evaluated the efficacy and impact on QoL of a 1% selenium disulphide-containing shampoo (SeS₂ shampoo) compared to a 2% ketoconazole shampoo.

Methods: This multi-centric, double-blinded, randomized 4-week study was conducted in 64 adult subjects with moderate to severe SSD (SSD severity score (SSSD) > 6). Shampoo was applied on the scalp and hair, according to product indications. Clinical examinations at baseline and on Day (D) 3, 7, 14, and 28 included the assessment of SSSD, total scales score (TSS, sum of adherent, and non-adherent scales), erythema, irritation, seborrhea, and itching. Self-evaluations included QoL and hair quality assessment (scales and greasiness).

Results: The SSSD improved in both groups as early as D3, after one application of shampoo. This significant (p < 0.001) improvement was -71% for SeS₂ and -69% for ketoconazole at D28. The decrease of the TSS was significant (p < 0.001) at D28 in both groups (-75% SeS₂ and -68% for ketoconazole). The SSSD severity of all subjects decreased to mild at D28. Signs and symptoms had significantly (p < 0.001) improved in both groups after 28 days. QoL improved earlier with SeS₂ than with ketoconazole shampoo. The cosmetic acceptability of SeS₂ shampoo was higher than that of ketoconazole shampoo. Both shampoos were very well tolerated.

Conclusion: SeS₂ shampoo is a reliable and well-tolerated alternative care to ketoconazole shampoo in patients with moderate to severe scalp seborrheic dermatitis.