None listed
Conditions
Brief summary
The aim of this study is to assess the local tolerability of an experimental ointment called AN2728. This ointment has been tested in 11 clinical trials to date, and is being developed as a treatment for patients with psoriasis. In the laboratory this ointment has been shown to reduce inflammatory chemicals in the body that are involved in inflammatory skin diseases. This study will help doctors find out how well people will tolerate the application of the ointment to sensitive areas in terms of any local reaction (ie. irritation, redness, itchiness). Participant's skin will be monitored closely at various times throughout the study to assess any effect that the drug has on their skin.
Interventions
AN2728 Topical Ointment, 2% will be applied to the specified areas (elbows, knees, groins, axillae, gluteal cleft, retroauricular areas, genitals and hairline) by the participants twice a day for 21 days.
Sponsors
CMAX - A division of IDT Australia, Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand and give written informed consent prior to the initiation of any protocol-related procedures. 2. Caucasian males and females, 18-55 years (inclusive) of age at the time of randomisation. 3. Willing and able to comply with study instructions and commit to all study visits.
Exclusion criteria
1. History of serious adverse reactions or hypersensitivity to any drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the IB. 2. Any clinically significant medical conditions or history of such conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this trial. 3. Abnormal physical findings of clinical significance or dermatological condition at the Screening examination or Baseline which would interfere with the objectives of the study. 4. Clinically significant abnormal laboratory values (as determined by the Investigator) at the Screening evaluation. 5. Chronic use of medications that would interfere with the objectives of the study (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) within 1 week of Baseline and during the study. 6. Not willing to refrain from shaving, the use of depilatories or other hair-removal activities in the treatment areas 2 days prior to enrollment and during the course of the study. 7. Not willing to refrain from all sexual contact during the treatment period and 24 h after the last dose of study drug. 8. Uncircumcised males. 9. Females who are breastfeeding or pregnant, or who intend to become pregnant during the time of their participation in the study. 10. Concurrent or recent (within 60 days of randomization) participation in another drug or device research study. 11. Considered by the Investigator to be unsuitable candidate for this study. 12. Use of AN2728 in a previous clinical trial.
Outcome results
None listed