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Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The rates of adverse reactions below were derived from two randomized, multi-center, vehicle-controlled clinical trials and one open-label study in subjects with head lice infestation.

Skin, scalp, and ocular irritation were monitored in the clinical trials. All subjects were queried about the presence of skin and scalp symptoms; the results are presented in Table 2.

Table 2: Monitored Adverse Reactions - Application Site Symptoms

Event Ulesfia Lotion Vehicle
Application site Irritation 2% (11/478) 1% (2/336)
Application site anesthesia & hypoesthesia 2% (10/478) 0% (0/336)
Pain 1% (5/478) 0% (1/336)

The subset of subjects who did not have pruritus, erythema, edema or pyoderma of skin and scalp, or ocular irritation prior to treatment were assessed for these signs and symptoms after treatment; the results are presented in Table 3.

Table 3: Monitored Adverse Reactions -Pruritus, Erythema, Pyoderma and Ocular Irritation with Onset After Treatment

Signs/Symptoms Ulesfia Lotion Vehicle
Pruritus 12% (14/116) 4% (3/67)
Erythema 10% (32/309) 9% (19/217)
Pyoderma 7% (22/308) 4% (10/230)
Ocular irritation 6% (26/428) 1% (3/313)

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation.