Safety and dosing of topical SOF-SKN cream in healthy adults

A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

This study will test whether different strengths of a topical SOF-SKN cream are safe and well tolerated when applied to the skin of healthy adults.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Noxopharm Limited (industry)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07072611 on ClinicalTrials.gov

What this trial studies

This early-phase, randomized, placebo-controlled study uses single and multiple ascending dose designs to characterize safety, tolerability, and pharmacokinetics of topical SOF-SKN in healthy volunteers. Part 1 (SAD) has four single-dose cohorts and Part 2 (MAD) has four multiple-dose cohorts, each at 0.25%, 0.5%, 1% and 2% concentrations. Up to 32 participants (maximum 16 per part) will receive either a single 2 g application or daily 2 g applications for 14 days with safety monitoring and PK sampling. Eligible participants are adults 18–64 with Fitzpatrick skin types I–IV and adequate back surface area, and the study is conducted at a single center in Melbourne, Australia.

Who should consider this trial

Good fit: Healthy adults aged 18–64 with Fitzpatrick skin types I–IV, no relevant allergies, sufficient back surface area, and willingness to avoid other topical products are the ideal candidates.

Not a fit: People with active inflammatory skin disease, allergic constitutions, recent hair removal or topical treatment at the application site, extensive back tattoos, or those outside the 18–64 age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this study could identify safe topical doses and schedules of SOF-SKN that support later trials in people with cutaneous lupus.

How similar studies have performed: Dose-escalation safety studies of topical agents have frequently guided further development, but SOF-SKN's specific safety and effectiveness in cutaneous lupus remain unproven.

Eligibility criteria

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 this trial is running

Melbourne, Victoria

• Doherty Clinical Trials — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Gisela Mautner, MD-PhD

Conditions: Cutaneous Lupus Erythematosus