Study of TP-04 in Participants With Papulopustular Rosacea

Recruiting at 4 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

37 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a gel called TP-04 on people with skin conditions. The gel is applied to the skin regularly for several weeks. It works by killing tiny organisms on the skin that may be causing the symptoms.

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.

Research Team

Jose Trevejo, MD, PhD

Principal Investigator

Tarsus Pharmaceuticals, Inc.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Lotilaner Gel, 2.0%
• Vehicle control gel

Participant Groups

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+