Table 3

Summary of adverse events

Adverse eventNo. of patientsSeverityStudy dayDuration daysSuspected to be drug related
Study A
Stinging sensation at application site4/10Mild–moderate13–22Yes
Dry skin1/10Moderate6Cont.Yes
Pruritus1/10Moderate612Yes
Infective exacerbation of atopic eczema1/10Severe97No
Cellulitis of eyelid1/10Mild55No
Pharyngitis1/10Mild75No
None5/10
Study B
Initial discomfort at site of application1/8Mild122Yes
Infective exacerbation of atopic eczema1/8Moderate921Yes
Inflamed skin after bath1/8Moderate102No
Viral cold1/8Mild2210No
Infected scalp lesions1/8Moderate185No
None3/8
Study C
Dry skin1/8Mild2Cont.Yes
Pruritus1/8Mild41No
Teething1/8Mild151No
Bronchospasm1/8Mild223No
Constipation1/8Mild32No
Cold1/8Mild515No
Sunburn1/8Mild103No
None3/8