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Tests treatment safety and results for Cutaneous Lupus Erythematosus
Official title Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
ClinicalTrials.gov ID: NCT07072611
What this study is testing
What is SOF-SKN 0.25%?
SOF-SKN 0.25% is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for cutaneous lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- No Allergies.
- Contraception.
You likely can't join if
- 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...
- Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.