Trial · NCT04475432

Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

NCT04475432, Phase 2, Phase 3, Completed, Tarsus Pharmaceuticals, Inc.; results first posted 2023-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis. Trials, record NCT04475432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04475432

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
NCT number: NCT04475432
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 421 participants, actual
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Conditions: Blepharitis
Interventions: TP-03, 0.25%, TP-03 Vehicle
First posted: 2020-07-17
Last updated: 2023-12-21
Results first posted: 2023-12-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants Cured Based on a Collarette Score at Day 43.	43 days	The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Secondary	The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	43 days	The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
Secondary	Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	43 days	The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Proportion of Participants Cured Based on a Collarette Score at Day 43.	43 days	Proportion cured	LEAST_SQUARES_MEAN
SECONDARY	The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	43 days	Proportion eradicated	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	43 days	Proportion cured	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Participants Cured Based on a Collarette Score at Day 43.	Active	0.439	Standard Error 0.034	Proportion cured
Proportion of Participants Cured Based on a Collarette Score at Day 43.	Control	0.072	Standard Error 0.018	Proportion cured
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	Active	0.677	Standard Error 0.032	Proportion eradicated
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	Control	0.173	Standard Error 0.026	Proportion eradicated
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	Active	0.139	Standard Error 0.024	Proportion cured
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	Control	0.01	Standard Error 0.007	Proportion cured

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	212
Overall Study	STARTED	Control	209
Overall Study	COMPLETED	Active	208
Overall Study	COMPLETED	Control	203
Overall Study	NOT COMPLETED	Active	4
Overall Study	NOT COMPLETED	Control	6

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Visual acuity reduced	Eye disorders	Active	6	212
other	Visual acuity reduced	Eye disorders	Control	6	209
other	Eye pain	Eye disorders	Active	3	212
other	Eye pain	Eye disorders	Control	3	209
other	Eye discharge	Eye disorders	Active	3	212
other	Eye discharge	Eye disorders	Control	2	209
other	Chalazion	Eye disorders	Active	1	212
other	Chalazion	Eye disorders	Control	3	209
other	Vision blurred	Eye disorders	Active	2	212
other	Vision blurred	Eye disorders	Control	2	209

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	0	212
Total, all-cause mortality	Control	0	209
Total, other adverse events	Active	37	212
Total, other adverse events	Control	39	209
Total, serious adverse events	Active	3	212
Total, serious adverse events	Control	1	209

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35965392	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active vs Control: deaths from any cause	Trial comparisons
Active vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04475432

GET https://conductscience.org/api/trials/v1/NCT04475432/events?page=2

API reference For AI assistants