Healthy participants
Conditions
Interventions
IMP 1 and 2
Vehicle
Sponsors
Armauer Hansen Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and/or female subjects of age 18+years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination & clinical laboratory tests. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion criteria
Exclusion criteria: 1. Evidence or history of clinically significant abnormalities 2. Subjects with any active skin condition at the application site that can possibly affecting drug absorption. 3. Subjects with a skin condition (Draize) score >0 of the test area immediately prior to first treatment application. 4. Subjects using topical prescriptions or non-prescription drugs within 14 days of the first treatment application. 5. Subjects not willing to avoid application of treatments such as lotions or creams on the application site throughout the study follow-up. 6. Pregnant and lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of serious adverse drug reaction(s) in comparison to placebo/vehicle for single patch test and for repeated open application tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes from baseline vital signs (blood pressure, pulse rate, body temp & respiratory rate) 2. Incidence and severity of treatment emergent adverse events 3. Incidence and magnitude of treatment emergent laboratory abnormalities 4. Changes from baseline on skin irritation assessment scores after treatment | — |
Countries
Ethiopia
Contacts
Public ContactFrehiwot Teka
Researcher
Outcome results
None listed