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Topical Agent

Lotilaner Gel, 2.0% (TP-04) for Papulopustular Rosacea

Phase 2
Waitlist Available
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through week 12
Awards & highlights

Study Summary

This trial investigates if a drug is safe & effective to treat rosacea, a common skin disease.

Eligible Conditions
  • Papulopustular Rosacea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in ECGs change in QRS interval in msec
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
Changes from baseline in vital signs change in height in cm
+10 more
Secondary outcome measures
Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline
Facial Inflammatory lesion counts - absolute change from baseline
Facial inflammatory lesion counts - percent change from baseline
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lotilaner Gel, 2.0% (TP-04)Experimental Treatment1 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-ControlledPlacebo Group1 Intervention
Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lotilaner Gel, 2.0%
2023
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,238 Total Patients Enrolled
Jose Trevejo, MD, PhDStudy DirectorTarsus Pharmaceuticals, Inc.
2 Previous Clinical Trials
182 Total Patients Enrolled

Media Library

Lotilaner Gel, 2.0% (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05838170 — Phase 2
Papulopustular Rosacea Research Study Groups: Lotilaner Gel, 2.0% (TP-04), Vehicle-Controlled
Papulopustular Rosacea Clinical Trial 2023: Lotilaner Gel, 2.0% Highlights & Side Effects. Trial Name: NCT05838170 — Phase 2
Lotilaner Gel, 2.0% (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838170 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any adverse effects associated with using Lotilaner Gel, 2.0% (TP-04)?

"Our safety assessment, which uses a scale of 1-3, yields Lotilaner Gel, 2.0% (TP-04) with an evaluation of two given this is only in Phase 2 and there are no clinical data suggesting efficacy yet."

Answered by AI

Are any US medical centers participating in this research project?

"The trial is recruiting from 5 major sites, including SKiN Centre for Dermatology in Peterborough and K. Papp Clinical Research in Waterloo, with Innovaderm Research Inc. located in Montréal being another prominent one; other locations are also available."

Answered by AI

How many individuals have chosen to partake in this experiment?

"Affirmative. The clinical trial's information on clinicaltrials.gov implies that the study is recruiting participants now, having been initially posted on March 1st 2023 and last updated April 20th 2023. 30 people are being sought out from 5 different medical hubs for this endeavor."

Answered by AI

Are elderly citizens over the age of eighty-five being accepted into this research effort?

"Those who are between 18 and 59 years old may partake in this trial."

Answered by AI

Who meets the requirements to be part of this medical research?

"In order to be considered, applicants must have papulopustular rosacea and reside within the age bracket of 18-59. The study is aiming to enroll a total of 30 individuals."

Answered by AI

Are there any vacancies left within this clinical trial for potential participants?

"Indeed, according to the information posted on clinicaltrials.gov, this experiment is currently enrolling participants. This trial initially appeared online in March 1st of 2023 and was most recently updated April 20th of the same year. The researchers are aiming to recruit 30 volunteers from 5 sites."

Answered by AI

What is the expected outcome of this experimental research?

"According to the study sponsor, Tarsus Pharmaceuticals, Inc., the principal evaluation criteria between Week 1 and Week 12 is a comparison of baseline vitals with respect to height in centimetres. In addition, this research endeavour will also be gauging secondary metrics such as absolute change from baseline in facial inflammatory lesion count; absolute change from baseline Investigator Global Assessmen (IGA) Score (0=clear; 4=severe); and percent variance from initial levels for facial inflammation lesions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TP-04 in Participants With Papulopustular Rosacea
2023. "Study of TP-04 in Participants With Papulopustular Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838170.
~18 spots leftby Apr 2025
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