Trial · NCT05550337

Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris

NCT05550337, Phase 3, Completed, Teva Pharmaceuticals USA; results first posted 2024-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris. Trials, record NCT05550337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05550337

On this page

Trial

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

Title: Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
NCT number: NCT05550337
Status: Completed
Phases: Phase 3
Enrollment: 807 participants, actual
Lead sponsor: Teva Pharmaceuticals USA
Conditions: Acne Vulgaris
Interventions: Trifarotene 0.005 % Topical Cream, AKLIEF®, Placebo
First posted: 2022-09-22
Last updated: 2024-09-26
Results first posted: 2024-09-26

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Primary Change in Inflammatory Lesion Counts	Baseline and 12 Weeks	Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Primary	Primary Change in Non-Inflammatory Lesion Count	Baseline and 12 Weeks	Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Change in Inflammatory Lesion Counts	Baseline and 12 Weeks	Per Protocol Population	Percent change	MEAN
PRIMARY	Primary Change in Non-Inflammatory Lesion Count	Baseline and 12 Weeks	Per Protocol Population	Percent change	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
Primary Change in Inflammatory Lesion Counts	Test: Trifarotene Cream, 0.005%	-72.86	Standard Deviation 33.364	Percent change
Primary Change in Inflammatory Lesion Counts	AKLIEF®	-78.83	Standard Deviation 23.547	Percent change
Primary Change in Inflammatory Lesion Counts	Vehicle Product	-34.12	Standard Deviation 38.332	Percent change
Primary Change in Non-Inflammatory Lesion Count	Test: Trifarotene Cream, 0.005%	-62.03	Standard Deviation 31.716	Percent change
Primary Change in Non-Inflammatory Lesion Count	AKLIEF®	-67.51	Standard Deviation 27.577	Percent change
Primary Change in Non-Inflammatory Lesion Count	Vehicle Product	-27.30	Standard Deviation 36.628	Percent change

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Test: Trifarotene Cream, 0.005%	269
Overall Study	STARTED	AKLIEF®	269
Overall Study	STARTED	Vehicle Product	269
Overall Study	COMPLETED	Test: Trifarotene Cream, 0.005%	241
Overall Study	COMPLETED	AKLIEF®	235
Overall Study	COMPLETED	Vehicle Product	241
Overall Study	NOT COMPLETED	Test: Trifarotene Cream, 0.005%	28
Overall Study	NOT COMPLETED	AKLIEF®	34
Overall Study	NOT COMPLETED	Vehicle Product	28

Source ClinicalTrials.gov

Adverse events162

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	Application site dryness	General disorders	Test: Trifarotene Cream, 0.005%	4	269
other	Application site dryness	General disorders	AKLIEF®	5	269
other	Application site dryness	General disorders	Vehicle Product	1	269
other	Application site erythema	General disorders	Test: Trifarotene Cream, 0.005%	0	269
other	Application site erythema	General disorders	AKLIEF®	4	269
other	Application site erythema	General disorders	Vehicle Product	0	269
other	Application site exfoliation	General disorders	Test: Trifarotene Cream, 0.005%	0	269
other	Application site exfoliation	General disorders	AKLIEF®	1	269
other	Application site exfoliation	General disorders	Vehicle Product	0	269
other	Application site pain	General disorders	Test: Trifarotene Cream, 0.005%	1	269

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test: Trifarotene Cream, 0.005%	23	269
Total, all-cause mortality	AKLIEF®	37	269
Total, all-cause mortality	Vehicle Product	18	269
Total, other adverse events	Test: Trifarotene Cream, 0.005%	23	269
Total, other adverse events	AKLIEF®	37	269
Total, other adverse events	Vehicle Product	18	269
Total, serious adverse events	Test: Trifarotene Cream, 0.005%	0	269
Total, serious adverse events	AKLIEF®	1	269
Total, serious adverse events	Vehicle Product	0	269

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT05550337

GET https://conductscience.org/api/trials/v1/NCT05550337/events?page=2

API reference For AI assistants