Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
Recruiting · NCT07072611 · Interventional (participants receive a specific treatment) · Lead sponsor: Noxopharm Limited
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSOF-SKN 0.25%SOF-SKN 0.5%SOF-SKN 1%SOF-SKN 2%
What this trial is about
The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2. Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Healthy Volunteers 18 to 64 years.
- Participants with Fitzpatrick skin type I to IV.
- Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.
- No Allergies.
- Contraception.
- Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.
Exclusion criteria
- Allergic constitution.
- Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.
- Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.
- Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.
- Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and/or suntan/burn that could interfere with the test field evaluation.
- Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and/or scabs) present in the target area on the back that could interfere with the test field evaluation.
- Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.
- Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.
Where it is running
1 location listed.
- Doherty Clinical Trials - Melbourne, Victoria, Australia