Tri-Luma Adverse Reactions

In the controlled clinical trials, adverse events were monitored in the 161 patients who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) patients who experienced at least one treatment-related adverse event during these studies. In the long term clinical study, from a total of 314 patients treated with TRI-LUMA cream for at least 180 cumulative days, there were 202 (64%) patients who experienced at least one treatment-related adverse event No significant increase in severity or incidence of adverse events was observed from long-term use of TRI-LUMA cream compared with events reported during the 8-week controlled clinical studies. The most frequently reported adverse events that were observed from the controlled clinical trials and the long term safety were erythema,
desquamation, and burning at the site of application. The number and percentages of these events were markedly lower in the long-term study than in the controlled clinical studies. The majority of these events were mild to moderate in severity.
Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with TRI-LUMA Cream from the controlled clinical studies and the long-term study are summarized (in decreasing order of frequency). (See Tables 3 and 4.)

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The severity, incidence and type of adverse events experienced from 6 months cumulative use were not significantly different from the events reported for all patients. The incidence of application site pigmentation changes that occurred in both the controlled and long-term safety studies included 11 occurrences of hypopigmentation in 27 patients. The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation,
perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, blurred vision. TRI-LUMA Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin whose occurrence should prompt discontinuation of therapy. Cutaneous hypersensitivity to the active ingredients of TRI-LUMA Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to TRI-LUMA Cream or its component.