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.