![]() ![]() Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.ĭermal tolerance was assessed in a 21-day cumulative irritation trial in 36 healthy subjects. Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE base were identified. ![]() Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.Ī trial enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE using repeat insult patch testing methodology. The most common adverse reactions (<1%) were local skin reactions, and occurred in the area of the application site, including: - Drying or flaking of the skin burning or tingling following application erythema pigmentation changes application site reaction including signs and symptoms of inflammation.Ĭontact dermatitis following application has been observed when applied under occlusion in dermal safety trials. The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1,056 subjects with recurrent herpes labialis treated 5 times daily for 5 days. ![]() Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. ![]()
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