Cutaneous Lupus ErythematosusEarly Phase 1HERACLESNCT07072611
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
A Early Phase 1 study testing SOF-SKN 0.25%, SOF-SKN 0.5% and SOF-SKN 1% in people with Cutaneous Lupus Erythematosus, run by Noxopharm Limited at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- SOF-SKN 0.25%, SOF-SKN 0.5% and SOF-SKN 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jul 2025to 5 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
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.
Read the detailed description
The study will contain four, single ascending dose-escalation cohorts and four multiple dose-escalation cohorts allowing an exploration of different doses of SOF-SKN with safety monitoring to ensure the safety of the participants.
A maximum of thirty-two (32) participants will be enrolled overall, with a maximum of sixteen (16) participants enrolled into each part of the study.
There is to be a 28-day Screening period (Day -28 to -1) for both Part 1 and 2 of the study.
Both SAD and MAD will include four treatment cohorts (0.25%, 0.5%, 1% and 2%) of SOF-SKN.
Participants enrolled Part 1 (SAD) will receive a single dose of 2 g Soft-SKN cream while the participants enrolled in Part 2 (MAD) will receive daily applications of 2 g SOF-SKN cream for 14 days.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- SOF-SKN 0.25%, SOF-SKN 0.5%, SOF-SKN 1%, SOF-SKN 2%, Placebo
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF-SKN 0.25%Drug
cream for topical application
SOF-SKN 0.5%Drug
cream for topical application
SOF-SKN 1%Drug
cream for topical application
SOF-SKN 2%Drug
cream for topical application
PlaceboDrug
cream for topical application
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Single application of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 0.25%; Drug: Placebo |
| Cohort 2 | Active comparator | Single application of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 0.5%; Drug: Placebo |
| Cohort 3 | Active comparator | Single application of 2 g SOF-SKN cream 10 mg/g (1% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 1%; Drug: Placebo |
| Cohort 4 | Active comparator | Single application of 2 g SOF-SKN cream 20 mg/g (2% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 2%; Drug: Placebo |
| Cohort 5 | Active comparator | Multiple applications of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 0.25%; Drug: Placebo |
| Cohort 6 | Active comparator | Multiple applications of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 0.5%; Drug: Placebo |
| Cohort 7 | Active comparator | Multiple applications of 2 g SOF-SKN cream 10 mg/g (1% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 1%; Drug: Placebo |
| Cohort 8 | Active comparator | Multiple applications of 2 g SOF-SKN cream 20 mg/g (2% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. Receives: Drug: SOF-SKN 2%; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Target Toxicities after a single treatment
Part 1: Percentage of Target Toxicities after a single application of study treatment
Measured: 4 days -3 days after last application of topical treatment
Percentage of Target Toxicities after two-week treatment
Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment
Measured: 17 days - 3 days after last dose of treatment
Percentage of Adverse events (AEs) after a single treatment
Part 1: Percentage of AEs after a single application of study treatment
Measured: 4 days -3 days after last application of topical treatment
Percentage of Adverse events (AEs) after two-week treatment
Part 2: Percentage of AEs following two weeks of daily application of study
Measured: 17 days - 3 days after last dose of treatment
Percentage of Serious Adverse events (SAEs) after a single treatment
Part 1: Percentage of SAEs after a single application of study treatment
Measured: 4 days -3 days after last application of topical treatment
Percentage of serious Adverse events (SAEs) after two-week treatment
Part 2: Percentage of SAEs following two weeks of daily application of study treatment.
Measured: 17 days - 3 days after last dose of treatment
Secondary outcomes (13)
Maximum Tolerated Dose (MTD) of a single application of SOF-SKN
To determine the MTD of a single application of SOF-SKN cream.
Measured: 4 days -3 days after last application of topical treatment
Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN
To determine the MTD of multiple applications following two weeks of daily application of study treatment with SOF-SKN cream.
Measured: 17 days - 3 days after last dose of treatment
Maximum concentration (Cmax) of a single application of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure. The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Time to reach Cmax (tmax) of a single application of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure. Time to reach Cmax (tmax), if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Area Under the Concentration-Time Curve (AUC) of a single application of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure. The Area Under the Concentration-Time Curve (AUC) will be calculated from Time Zero to the Last Measurable Plasma Concentration (AUC0-last), if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
AUC Extrapolated to Infinity (AUC0-inf) of a single application of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure. The AUC Extrapolated to Infinity (AUC0-inf) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Half-life (t1/2) of a single application of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure. The Half-life (t1/2) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Maximum concentration (Cmax) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Time to reach Cmax (tmax) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The Time to reach Cmax (tmax) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Area Under the Concentration-Time Curve (AUC) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The Area Under the Concentration-Time Curve (AUC) Calculated from Time Zero to the Last Measurable Plasma Concentration (AUC0-last) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
AUC Extrapolated to Infinity (AUC0-inf) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The AUC Extrapolated to Infinity (AUC0-inf) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Half-life (t1/2) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The Half-life (t1/2) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Drug Accumulation Ratio (Rac) for multiple applications of SOF-SKN
PK parameters will be calculated to determine the degree of systemic exposure The Drug Accumulation Ratio (Rac) will be calculated, if possible, as minimal systemic exposure is expected.
Measured: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start14 Jul 2025
- Primary completion27 Dec 2025
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noxopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072611
- Sponsor's protocol ID
- PHA-001
- Acronym
- HERACLES
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
- ClinicalTrials.gov ID
- NCT07072611
- Acronym / sponsor ID
- HERACLES / PHA-001
- Conditions
- Cutaneous Lupus Erythematosus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Noxopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will contain four, single ascending dose-escalation cohorts and four multiple dose-escalation cohorts allowing an exploration of different doses of SOF-SKN with safety monitoring to ensure the safety of the participants.
A maximum of thirty-two (32) participants will be enrolled overall, with a maximum of sixteen (16) participants enrolled into each part of the study.
There is to be a 28-day Screening period (Day -28 to -1) for both Part 1 and 2 of the study.
Both SAD and MAD will include four treatment cohorts (0.25%, 0.5%, 1% and 2%) of SOF-SKN.
Participants enrolled Part 1 (SAD) will receive a single dose of 2 g Soft-SKN cream while the participants enrolled in Part 2 (MAD) will receive daily applications of 2 g SOF-SKN cream for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: SOF-SKN 0.25%, Drug: PlaceboSingle application of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 2 | Active comparator | Drug: SOF-SKN 0.5%, Drug: PlaceboSingle application of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 3 | Active comparator | Drug: SOF-SKN 1%, Drug: PlaceboSingle application of 2 g SOF-SKN cream 10 mg/g (1% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 4 | Active comparator | Drug: SOF-SKN 2%, Drug: PlaceboSingle application of 2 g SOF-SKN cream 20 mg/g (2% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 5 | Active comparator | Drug: SOF-SKN 0.25%, Drug: PlaceboMultiple applications of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 6 | Active comparator | Drug: SOF-SKN 0.5%, Drug: PlaceboMultiple applications of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 7 | Active comparator | Drug: SOF-SKN 1%, Drug: PlaceboMultiple applications of 2 g SOF-SKN cream 10 mg/g (1% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Cohort 8 | Active comparator | Drug: SOF-SKN 2%, Drug: PlaceboMultiple applications of 2 g SOF-SKN cream 20 mg/g (2% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOF-SKN 0.25%cream for topical application | Drug | Cohort 1, Cohort 5 |
| SOF-SKN 0.5%cream for topical application | Drug | Cohort 2, Cohort 6 |
| SOF-SKN 1%cream for topical application | Drug | Cohort 3, Cohort 7 |
| SOF-SKN 2%cream for topical application | Drug | Cohort 4, Cohort 8 |
| Placebocream for topical application | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Percentage of Target Toxicities after a single treatment
Time frame: 4 days -3 days after last application of topical treatment
Part 1: Percentage of Target Toxicities after a single application of study treatment
Percentage of Target Toxicities after two-week treatment
Time frame: 17 days - 3 days after last dose of treatment
Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment
Percentage of Adverse events (AEs) after a single treatment
Time frame: 4 days -3 days after last application of topical treatment
Part 1: Percentage of AEs after a single application of study treatment
Percentage of Adverse events (AEs) after two-week treatment
Time frame: 17 days - 3 days after last dose of treatment
Part 2: Percentage of AEs following two weeks of daily application of study
Percentage of Serious Adverse events (SAEs) after a single treatment
Time frame: 4 days -3 days after last application of topical treatment
Part 1: Percentage of SAEs after a single application of study treatment
Percentage of serious Adverse events (SAEs) after two-week treatment
Time frame: 17 days - 3 days after last dose of treatment
Part 2: Percentage of SAEs following two weeks of daily application of study treatment.
13 secondary outcomes
Maximum Tolerated Dose (MTD) of a single application of SOF-SKN
Time frame: 4 days -3 days after last application of topical treatment
Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN
Time frame: 17 days - 3 days after last dose of treatment
Maximum concentration (Cmax) of a single application of SOF-SKN
Time frame: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Time to reach Cmax (tmax) of a single application of SOF-SKN
Time frame: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Area Under the Concentration-Time Curve (AUC) of a single application of SOF-SKN
Time frame: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
AUC Extrapolated to Infinity (AUC0-inf) of a single application of SOF-SKN
Time frame: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Half-life (t1/2) of a single application of SOF-SKN
Time frame: 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
Maximum concentration (Cmax) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Time to reach Cmax (tmax) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Area Under the Concentration-Time Curve (AUC) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
AUC Extrapolated to Infinity (AUC0-inf) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Half-life (t1/2) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Drug Accumulation Ratio (Rac) for multiple applications of SOF-SKN
Time frame: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Cutaneous Lupus Erythematosus
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SOF-SKN 0.25%, SOF-SKN 0.5% and SOF-SKN 1% in people with Cutaneous Lupus Erythematosus, run by Noxopharm Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Target Toxicities after a single treatment (time frame: 4 days -3 days after last application of topical treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.