Lotilaner Gel for Papulopustular Rosacea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gel treatment called TP-04 (Lotilaner Gel, 2.0%) to determine its safety and effectiveness for people with papulopustular rosacea, a skin condition causing redness and bumps on the face. Participants will apply either the TP-04 gel or a placebo gel to their faces for 12 weeks. Ideal candidates have experienced moderate to severe rosacea for at least six months and frequent flare-ups that impact daily life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective new therapy.
Will I have to stop taking my current medications?
The trial requires participants to stop using certain medications before starting. You must stop using oral retinoids, high-dose vitamin A, certain hormonal therapies, systemic immunosuppressants, and specific topical products for rosacea within specified periods before Day 1. Check with the trial team to see if your current medications are affected.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Lotilaner Gel, 2.0% (TP-04), is generally safe and well-tolerated. In earlier studies, a similar version of Lotilaner proved safe with no major side effects. This treatment targets and kills mites, which can help reduce symptoms of skin conditions like rosacea. Although this specific gel remains under study, safety data from other Lotilaner products appear promising. Prospective participants should consult a healthcare provider to discuss potential risks and benefits before joining a trial.12345
Why do researchers think this study treatment might be promising for rosacea?
Most treatments for papulopustular rosacea, like topical metronidazole and azelaic acid, work by reducing inflammation and bacterial growth. But Lotilaner Gel, 2.0% (TP-04) stands out because it uses lotilaner, an ingredient originally developed as an anti-parasitic. This unique approach targets the Demodex mites, which are believed to play a role in rosacea. Researchers are excited about Lotilaner Gel because it offers a novel mechanism of action that could provide relief to patients who don't respond well to traditional anti-inflammatory or antibacterial therapies.
What evidence suggests that Lotilaner Gel, 2.0% might be an effective treatment for papulopustular rosacea?
Research suggests that Lotilaner Gel, 2.0% (TP-04), which participants in this trial may receive, could help treat papulopustular rosacea. Lotilaner is a medicine that can paralyze and kill mites, including Demodex mites, which are believed to contribute to rosacea. This gel has effectively treated other mite-related conditions. Although specific data for papulopustular rosacea remains limited, the active ingredient's ability to target mites indicates potential benefits. Early results support its mechanism, offering hope for people with this skin condition.13678
Who Is on the Research Team?
Jose Trevejo, MD, PhD
Principal Investigator
Tarsus Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply Lotilaner Gel, 2.0% (TP-04) or vehicle control gel on the face BID for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lotilaner Gel, 2.0%
- Vehicle control gel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tarsus Pharmaceuticals, Inc.
Lead Sponsor