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Sebclair’s antifungal and anti-inflammatory activity significantly improves seborrheic dermatitis symptoms

Prof. Neal Bhatia
05 Aug 2016
Although topical corticosteroids are effective for the treatment of seborrheic dermatitis, long-term use of these agents is limited by side effects. Moreover, increased understanding of the possible contribution of yeast species to the pathogenesis of the disease suggests that corticosteroids may also be limited by their lack of antifungal efficacy. By contrast, novel nonsteroidal treatments offer great promise. At the 2nd Asia Pacific Meeting of Experts in Dermatology (APMED) held recently in Hanoi, Vietnam, Associate Professor Neal Bhatia, from the Harbor-UCLA Medical Center, Los Angeles, California, US, discussed the potential benefits of new agents such as SebclairTM (Menarini), which combines anti-inflammatory and antifungal properties to effectively treat the symptoms of seborrheic dermatitis.

Introduction

“Improved understanding of the pathogenesis and mechanisms of seborrheic dermatitis has provided us with a number of new agents that can help maintain and control the disease and minimize flares,” said Bhatia.

Malassezia
(formerly Pityrosporum) yeast species, particularly M. furfur, appear to play a key role in the pathogenesis of the disease. “Although Malassezia yeast are found in both healthy skin and seborrheic dermatitis lesions, studies performed in Pakistan, Japan, Greece, Sweden and the US have shown that they occur in greater numbers in affected skin and other studies have shown that the symptoms and severity of seborrheic dermatitis may be reduced by reducing yeast populations in the skin,” said Bhatia. “These findings suggest that some people may not be able to clear the yeasts as effectively as others and instead develop an inflammatory reaction to them.” [J Eur Acad Dermatol Venereol 2004;18:13-26, Curr Top Med Mycol 1995;6:95-112; J Eur Acad Dermatol Venereol 2004;18:13-26]

The primary target of therapy
At present it is unclear whether M. furfur or inflammation should be the primary target of treatment. “The question is whether the anti-fungal activity against M. furfur is sufficient to slow or minimize the inflammatory process,” said Bhatia.

“Topical treatments that do not have sufficient anti-inflammatory or anti-fungal activity may be of limited efficacy. For example, monotherapy with topical corticosteroids may not prevent disease flares or relapse as although these agents treat the inflammatory symptoms, they have no effect against the aetiological trigger, that is, yeast species such as M. furfur.

By contrast Sebclair (aka Promiseb), a nonsteroidal cream, has both antifungal and anti-inflammatory properties and is promising as it is not only effective at treating inflammatory symptoms, but it also reduces the incidence of relapse and disease flares.” [J Drugs Dermatol 2013;12:796-798]

Indeed, the strategy of combining antifungal and anti-inflammatory agents has already been employed clinically. Patients may use an antifungal shampoo a few times a week along with intermittent topical steroids, for example. MAS063D, a non-steroidal cream that has both anti-fungal and anti-inflammatory properties, has also been shown to effectively reduce symptoms of allergic dermatitis in both adults and children [Eur J Dermatol 2005;15:31-36, Eur J Dermatol 2008; 18:317-321]

Sebclair significantly improves erythema, pruritus, scaling
Bhatia reported the findings from a pivotal study that compared the efficacy of Sebclair cream with that of the corticosteroid desonide in 77 patients with mild-to-moderate facial seborrheic dermatitis. The creams were applied twice daily for up to 28 days (treatment was discontinued at day 14 if the skin was clear). At study end, mean Investigator Global Assessment (IGA) scores for both Sebclair and desonide were significantly reduced from baseline levels as were symptoms of erythema, pruritus and scaling (Figures 1,2).
Sebclair Figure 1
Sebclair Figure 2

Relapse rate lower with Sebclair vs desonide
Although there were no significant differences between Sebclair and desonide with respect to the endpoints of IGA score or erythema, significantly more Sebclair vs desonide recipients deemed clear at day 14 remained clear at day 28 (p=0.017)(Figure 3). Both agents were well tolerated. [Clin Dermatol 2009;27:S48-53]
Sebclair Figure 3

“Sebclair showed comparable efficacy to desonide with the added benefit of fewer relapses,” noted Bhatia. The researchers suggested that the efficacy of the nonsteroidal cream was due to its ability to reduce colonization by Malassezia yeast species and thus the trigger for the inflammatory response.

Sebclair has clinically significant antifungal activity
A study performed in seborrheic dermatitis patients supports this contention. In the single centre, open-label, bilateral pilot study, Sebclair cream was applied twice daily to designated target areas on the chests of 10 healthy volunteers for 7 days. The number of colony-forming units of Malassezia yeast species was determined by tape stripping and compared with baseline between the treated and untreated sides. Seven of the 10 subjects were positive for Malassezia and colony counts ranged from 1–195/tape, but the percentage reduction in yeast density from baseline was significantly greater on the treated side of the chest (94 vs 49 percent, p=0.03), proving that Sebclair has clinically significant antifungal activity.[Clin Dermatol 2009;27:S44-47]

Conclusion
“The two key ingredients included in Sebclair, glycerrhetinic acid and piroctone olamine, have both been shown to have anti-inflammatory and antifungal activity and thus both target the disease process itself, not just the symptoms,” said Bhatia. “This unique combination of properties makes Sebclair a promising nonsteroidal first-line therapy for patients with mild seborrheic dermatitis and it can also be used for maintenance therapy after remission. For patients with moderate disease, Sebclair may be used with or without prescription corticosteroids,” he concluded.
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