A pilot study on seborrheic dermatitis using pramiconazole as a potent oral anti-Malassezia agent.
BACKGROUND
Seborrheic dermatitis is considered to be a Malassezia-driven disease. Little objective information is available so far from biometrological quantitative assessments of this skin condition. Pramiconazole is a novel triazole with potent in vitro antifungal activity, especially against Malassezia spp.


OBJECTIVE
To study the sequential effects of pramiconazole on Malassezia, inflammation and epidermal changes.


METHODS
This study was performed in 2 groups of subjects suffering from seborrheic dermatitis. The first group (n = 17) remained untreated and was used as control. Clinical, mycological and biometrological assessments were performed at inclusion and during the following 2 weeks. The second group of subjects (n = 10) received a single 200-mg oral dose of pramiconazole at inclusion. Clinical, mycological and biometrological evaluations were performed before and during 1 month following the single antifungal intake. For both parts of the study, several parameters were assessed including yeast density, desquamation, erythema, itching and sebum excretion.


RESULTS
In the control group, no significant changes were observed in any of the parameters during the observation period. The findings were markedly different in the pramiconazole-treated subjects. The yeast density was significantly improved on days 3, 7 and 28. Desquamation, erythema, itching, and the global clinical evaluation as assessed by the patients and investigators became significantly improved on days 7 and 28. A trend in decrease of scaliness was noted. No effect on sebum excretion was evidenced. In conclusion, a single 200-mg dose of pramiconazole exhibitsin vivo efficacy in controlling some important clinical aspects of seborrheic dermatitis. Following a reduction in the number of yeasts on day 3, a decrease in the severity of clinical signs and symptoms occurred from day 7 onwards. Sebum excretion appeared uninvolved in the clearing process of seborrheic dermatitis.


CONCLUSIONS
A single 200-mg dose of pramiconazole appears to abate seborrheic dermatitis. The density in Malassezia present on lesional skin is first decreased, followed by clearing of the clinical signs.
Piérard
Gérald E
GE
Department of Dermatopathology, University Hospital of Liège, Liège, Belgium. gerald.pierard@ulg.ac.be
Ausma
Jannie
J
Henry
Frédérique
F
Vroome
Valérie
V
Wouters
Luc
L
Borgers
Marcel
M
Cauwenbergh
Geert
G
Piérard-Franchimont
Claudine
C
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000382:microbiology*; D004305:Dose-Response Relationship, Drug; D004817:Epidermis / Q000382:microbiology / Q000473:pathology; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D008290:Malassezia / Q000187:drug effects* / Q000254:growth & development; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014230:Triazoles / Q000494:pharmacology / Q000627:therapeutic use*
D000935:Antifungal Agents; D007093:Imidazoles; D014230:Triazoles; C482452:pramiconazole