Lotilaner Gel for Papulopustular Rosacea

No longer recruiting at 5 trial locations

Overseen By Jeremy Lim, PharmD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Tarsus Pharmaceuticals, Inc.

Must not be taking: Oral retinoids, Systemic immunosuppressants

Disqualifiers: Pregnancy, Cancer, Chronic infectious disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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

Participant has moderate or severe persistent erythema associated with PPR, as defined by a CEA score of 3 (moderate) or 4 (severe) at the screening and Day 1 visits.

Participant has SSSB1 > 5 D/cm² or SSSB2 > 10 D/cm² at the screening and Day 1 visits.

For male participant involved in any sexual intercourse that could lead to pregnancy, participant must agree to use one of the highly effective contraceptive methods listed in Inclusion Criterion #9, from Day 1 until at least 6 months after the last study product application. If the female partner of a male participant use any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from at least 4 weeks before Day 1 until at least 6 months after the last study product application.

Exclusion Criteria

Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).

Participant has used oral retinoids (eg, isotretinoin) within 52 weeks prior to Day 1 or high-dose vitamin A (> 10,000 IU/day) within 26 weeks prior to Day 1.

Participant has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply Lotilaner Gel, 2.0% (TP-04) or vehicle control gel on the face BID for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lotilaner Gel, 2.0%
• Vehicle control gel

How Is the Trial Designed?

Group I: Lotilaner Gel, 2.0% (TP-04) Experimental Treatment 1 Intervention

Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks.

Group II: Vehicle-Controlled Placebo Group 1 Intervention

Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks.

Who Is Running the Clinical Trial?

Tarsus Pharmaceuticals, Inc.

Lead Sponsor

Trials

10

Recruited

1,300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05838170

Study of TP-04 in Participants With Papulopustular Rosacea

The investigational product (Lotilaner Gel, 2.0% [TP-04]) or vehicle control gel will be applied topically on the face twice daily (BID) during the study.

2.

ir.tarsusrx.com

ir.tarsusrx.com/news-releases/news-release-details/tarsus-provides-2025-update-accelerating-launch-xdemvyr-and

Accelerating the Launch of XDEMVY® and Establishing ...

TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by ...

3.

nasdaq.com

nasdaq.com/articles/tarsus-pharmaceuticals-advances-tp-04-ocular-rosacea-treatment-phase-2-study-set-2025

Tarsus Pharmaceuticals Advances TP-04 for Ocular ...

TP-04 is an investigational ophthalmic gel for potential treatment of Ocular Rosacea, a prevalent eye disease with no FDA-approved therapies.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10689680/

Emerging Medical Therapies in Rosacea: A Narrative Review

TP-04 is a novel topical gel formulation of lotilaner that has demonstrated anti-parasitic activity against Demodex mites by inhibiting parasite ...

5.

firstwordpharma.com

firstwordpharma.com/story/5937876

Tarsus Reports Strong Fourth Quarter and Full-Year 2024 ...

TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11825414/

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25 ...

In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week ...

7.

tarsusrx.com

tarsusrx.com/pipeline/tp-04/

TP-04

Lotilaner is a well-characterized antiparasitic agent that paralyzes and kills Demodex mites by selectively inhibiting parasite-specific GABA-chloride channels.

8.

sec.gov

sec.gov/Archives/edgar/data/1819790/000181979025000077/exhibit991tarsus512025pres.htm

Document

TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by selectively ...