Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.
The study was designed to assess the sensitization potential of diacerein 1% ointment in comparison to vehicle ointment and 0.9% saline (negative irritant control) under occlusive patch conditions, at 3 randomly assigned, adjacent skin sites, 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total) for determining sensitization potential.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
234
All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
TKL Research
Fair Lawn, New Jersey, United States
Observed Sensitization
The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period. Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.
Time frame: 56 days
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