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Can a new topical cream tame cutaneous lupus?

NCT ID NCT07072611

Disease control Sponsor: Noxopharm Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This early-stage trial tests the safety and tolerability of SOF-SKN, a cream applied to the skin, in healthy volunteers aged 18 to 64. The study has two parts: one applies a single dose, and the other applies daily doses for two weeks, with escalating strengths. Researchers monitor for side effects and determine the maximum tolerated dose. The goal is to gather initial safety data before testing SOF-SKN in people with cutaneous lupus erythematosus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SOF-SKN cream applied to the skin
What this could lead to
If safe and well-tolerated, SOF-SKN could become a topical treatment option for cutaneous lupus erythematosus, potentially reducing skin lesions with fewer side effects than systemic drugs.
What could go wrong
This is an early-phase trial in healthy volunteers, so it will not show whether SOF-SKN works for lupus. The cream may cause skin irritation or other side effects, and further trials are needed to assess its effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

24 people

The number who actually took part.

Started

Jul 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous lupus erythematosus

Contacts and locations

Locations

  • Doherty Clinical Trials

    Melbourne, Victoria, Australia

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