ADVERSE REACTIONS
Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.
The safety data presented in Table 1 (below) reflect exposure to Extina Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Extina Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.
Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials
| Adverse Reactions | Extina Foam
N = 672
n (%) | Vehicle Foam
N = 497
n (%) |
Subjects with an
Adverse Reaction | 188 (28%) | 122 (25%) |
| Application site burning | 67 (10%) | 49 (10%) |
| Application site reaction | 41 (6%) | 24 (5%) |
Application site reactions that were reported in < 1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth.
Dermal Safety Studies
In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Extina Foam. Extina Foam may cause contact sensitization.
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