Actively Recruiting
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
Led by Noxopharm Limited · Updated on 2025-07-20
32
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 64 years
- Fitzpatrick skin type I to IV
- Back surface area at least 24 x 30 cm to allow two 10 x 30 cm application areas separated by 4 cm
- No allergies
- Use of contraception
- Willing to avoid moisturizers and other topical products on the back 24 hours before and during the study
You will not qualify if you...
- Allergic constitution
- Use of antihistamines or topical drugs at the application site within 72 hours before starting treatment
- Hair removal treatments such as laser, shaving, or waxing on the target area within 1 week before screening
- Hypertrichosis on the back
- Tattoos covering more than 30% of the back surface area
- Presence of inflammatory skin conditions like atopic dermatitis, eczema, psoriasis, or extensive acne on the back
- Suntan or sunburn that could affect test area evaluation
- Non-inflammatory skin lesions or changes on the back that could interfere with evaluation
- History or presence of melanoma or non-melanoma skin cancer within the last 3 years
- Any other skin disease or visible skin condition that might interfere with test evaluation according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Doherty Clinical Trials
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
G
Gisela Mautner, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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