Trial · NCT04784091

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

NCT04784091, Phase 3, Completed, Tarsus Pharmaceuticals, Inc.; results first posted 2023-12-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis. Trials, record NCT04784091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04784091

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Trial

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

Title: Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
NCT number: NCT04784091
Status: Completed
Phases: Phase 3
Enrollment: 412 participants, actual
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Conditions: Blepharitis
Interventions: TP-03, TP-03 Vehicle
First posted: 2021-03-05
Last updated: 2023-12-21
Results first posted: 2023-12-21

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	43 days	The proportion of subjects 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 Their Demodex Mites Eradicated.	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	The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	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.
Secondary	The Proportion of Participants Cured Based on Erythema Score.	43 days	The proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema 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

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	43 days	Proportion cured	LEAST_SQUARES_MEAN
SECONDARY	The Proportion of Participants With Their Demodex Mites Eradicated.	43 days	Proportion eradicated	LEAST_SQUARES_MEAN
SECONDARY	The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	43 days	Proportion cured	MEDIAN
SECONDARY	The Proportion of Participants Cured Based on Erythema Score.	43 days	Proportion cured	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	Active	0.547	Standard Error 0.035	Proportion cured
The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	Control	0.122	Standard Error 0.023	Proportion cured
The Proportion of Participants With Their Demodex Mites Eradicated.	Active	0.499	Standard Error 0.036	Proportion eradicated
The Proportion of Participants With Their Demodex Mites Eradicated.	Control	0.14	Standard Error 0.024	Proportion eradicated
The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	Active	0.187	Standard Error 0.028	Proportion cured
The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	Control	0.039	Standard Error 0.014	Proportion cured
The Proportion of Participants Cured Based on Erythema Score.	Active	0.303	Standard Error 0.033	Proportion cured
The Proportion of Participants Cured Based on Erythema Score.	Control	0.091	Standard Error 0.02	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	203
Overall Study	STARTED	Control	209
Overall Study	COMPLETED	Active	193
Overall Study	COMPLETED	Control	200
Overall Study	NOT COMPLETED	Active	10
Overall Study	NOT COMPLETED	Control	9

Source ClinicalTrials.gov

Adverse events40

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	5	203
other	Visual acuity reduced	Eye disorders	Control	6	209
other	Dry eye	Eye disorders	Active	4	203
other	Dry eye	Eye disorders	Control	2	209
other	Punctate keratitis	Eye disorders	Active	4	203
other	Punctate keratitis	Eye disorders	Control	1	209
other	Chalazion	Eye disorders	Active	3	203
other	Chalazion	Eye disorders	Control	0	209
other	Conjunctival haemorrhage	Eye disorders	Active	2	203
other	Conjunctival haemorrhage	Eye disorders	Control	1	209

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	0	203
Total, all-cause mortality	Control	0	209
Total, other adverse events	Active	49	203
Total, other adverse events	Control	28	209
Total, serious adverse events	Active	4	203
Total, serious adverse events	Control	3	209

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37285925	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/NCT04784091

GET https://conductscience.org/api/trials/v1/NCT04784091/events?page=2

API reference For AI assistants