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Placebo‐controlled evaluation of the irritant potential of tacalcitol (1α, 24‐dihydroxyvitamin D 3 ) in healthy volunteers
Author(s) -
Schlotmann K.,
Ortland C.,
Neumann N. J.,
Ruzicka T.,
Lehmann P.
Publication year - 2000
Publication title -
contact dermatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.524
H-Index - 96
eISSN - 1600-0536
pISSN - 0105-1873
DOI - 10.1034/j.1600-0536.2000.042005260.x
Subject(s) - erythema , transepidermal water loss , irritation , medicine , dermatology , triamcinolone acetonide , placebo , infiltration (hvac) , psoriasis , surgery , pathology , immunology , physics , alternative medicine , stratum corneum , thermodynamics
In the treatment of psoriasis with topical vitamin D 3 analogues, lesional and perilesional irritation is the main side‐effect. The aim of this study was to investigate whether local side‐effects generated by tacalcitol, a vitamin D 3 analogue, show concentration dependence. 3 different concentrations of tacalcitol (0.4; 4; 40 μg/g ointment) and the vehicle were applied on normal skin of the back of 25 healthy volunteers under occlusive conditions for 5 days. Assessment of erythema, infiltration and scaling as well as measurement of transepidermal water loss (TEWL) was performed on days 1 to 5. On day 5, additional skin barrier tests (DMSO test, alkali resistance test) were performed. Erythema and slight infiltration, but no scaling, were observed in a number of subjects without significant differences. TEWL also did not show significant differences for the test formulations, though there was a tendency towards lower values in the untreated areas. In the skin barrier tests, a tendency towards higher alkali resistance in the test areas treated with 40 μg tacalcitol/g ointment was detected. Thus, under occlusive conditions, the irritant potential of tacalcitol is very low. There is no convincing evidence of concentration dependence in irritation generated by tacalcitol when applied under occlusive conditions.