Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LEO Pharma
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability and willingness to comply with all the study requirements/procedures
Age ≥ 18 and ≤65 years
Primary bullous/non-bullous impetigo or SITL
Patients suffering from primary bullous/non-bullous impetigo must have:
* Not more than 10 discrete lesions, and
* A total lesional area ≥ 1 cm2 and ≤ 100 cm2, and
* Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
* Total SIRS score equal to or ≥ 8
Patients suffering from SITL must have:
* A total infected area of the traumatic lesion ≥ 1 cm2 and ≤ 100 cm2, and
* Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
* Total SIRS score ≥ 8, and
* SITL not caused by burns or animal/human bite
Amenable for treatment with topical antibiotic alone
Body Mass Index ≥18 and ≤ 35 kg/m2.
You may not be if
Immunosuppressed state or other serious systemic disease
Signs and/or symptoms of systemic infection, such as malaise and fever or local adenopathy and fever
Unwillingness to abstain from use of any other topical products including emollients on the lesional area during the study
Systemic treatment with antibacterials or immunosuppressive agents (e.g. corticosteroids) within 2 days before day 1 (inhaled/intranasal steroids may be used)
Topical treatment with antibacterials, immunosuppressive agents (e.g. corticosteroids) or antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide, iodine) on the lesional area within 2 days before day 1
Indication for surgical or systemic treatment of the SITL/impetigo
Known or suspected hypersensitivity to any of the components of the study medication
Participation in any other interventional clinical trial or use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to day 1
Previously enrolled in this study
A blood alcohol content ≥ 0.08% as determined by a Breathalyzer test
Known or suspected history of alcohol abuse/alcoholism or drug abuse
Known or suspected impairment of liver function
Heart rhythm disturbances or clinically significant quantitative or qualitative abnormality in the pretreatment ECG
Blood donation in excess of 500mL within 56 days before day 1 or donation during the study or within 3 days of leaving the study.
