Trial Outcomes & Findings for A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302) (NCT NCT03168334)

Last Updated: 2021-04-01

Results Overview

For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

801 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2021-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	IDP-123 Lotion IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion IDP-123 Vehicle Lotion
Overall Study STARTED	397	404
Overall Study COMPLETED	345	366
Overall Study NOT COMPLETED	52	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion	Total n=801 Participants Total of all reporting groups
Age, Continuous	20.1 years STANDARD_DEVIATION 6.48 • n=5 Participants	20.5 years STANDARD_DEVIATION 6.81 • n=7 Participants	20.3 years STANDARD_DEVIATION 6.65 • n=5 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	262 Participants n=7 Participants	513 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	142 Participants n=7 Participants	288 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	54 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) White	298 Participants n=5 Participants	303 Participants n=7 Participants	601 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Lesion counts Non-inflammatory lesions	41.8 lesions STANDARD_DEVIATION 17.87 • n=5 Participants	40.6 lesions STANDARD_DEVIATION 16.31 • n=7 Participants	41.2 lesions STANDARD_DEVIATION 17.10 • n=5 Participants
Lesion counts Inflammatory lesions	28.0 lesions STANDARD_DEVIATION 7.32 • n=5 Participants	27.9 lesions STANDARD_DEVIATION 7.10 • n=7 Participants	28.0 lesions STANDARD_DEVIATION 7.21 • n=5 Participants
Evaluator's Global Severity Score Moderate	358 Participants n=5 Participants	357 Participants n=7 Participants	715 Participants n=5 Participants
Evaluator's Global Severity Score Severe	39 Participants n=5 Participants	47 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Absolute Change in Mean Lesion Counts at Week 12 Non-inflammatory lesions	-24.6 lesion counts Standard Deviation 15.33	-16.6 lesion counts Standard Deviation 15.48
Absolute Change in Mean Lesion Counts at Week 12 Inflammatory lesions	-16.7 lesion counts Standard Deviation 9.49	-13.4 lesion counts Standard Deviation 9.37

PRIMARY outcome

Timeframe: Baseline to Week 12

Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"	29.6 percentage of participants	17.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Percentage Change in Mean Lesion Counts at Week 12 Non-inflammatory lesions	-60.00 percentage change Standard Deviation 34.680	-41.58 percentage change Standard Deviation 35.239
Percentage Change in Mean Lesion Counts at Week 12 Inflammatory lesions	-59.50 percentage change Standard Deviation 33.382	-48.95 percentage change Standard Deviation 32.898

SECONDARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)	34.5 percentage of participants	20.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Percentage Change in Mean Lesion Counts at Week 8 Inflammatory lesions	-50.38 percentage change Standard Deviation 32.917	-41.66 percentage change Standard Deviation 32.874
Percentage Change in Mean Lesion Counts at Week 8 Non-inflammatory lesions	-48.45 percentage change Standard Deviation 36.497	-30.92 percentage change Standard Deviation 36.772

SECONDARY outcome

Timeframe: Baseline to Week 4

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=397 Participants IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=404 Participants IDP-123 Vehicle Lotion
Percentage Change in Mean Lesion Counts at Week 4 Non-inflammatory lesions	-35.03 percentage change Standard Deviation 32.776	-24.12 percentage change Standard Deviation 33.040
Percentage Change in Mean Lesion Counts at Week 4 Inflammatory lesions	-32.31 percentage change Standard Deviation 32.906	-31.55 percentage change Standard Deviation 32.954

Adverse Events

IDP-123 Lotion

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Vehicle Lotion

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IDP-123 Lotion n=387 participants at risk IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=392 participants at risk IDP-123 Vehicle Lotion
Surgical and medical procedures Abortion induced	0.26% 1/387 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.	0.00% 0/392 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.
Psychiatric disorders Suicidal ideation	0.00% 0/387 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.	0.26% 1/392 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.

Other adverse events

Other adverse events
Measure	IDP-123 Lotion n=387 participants at risk IDP-123 (Tazarotene 0.045%) Lotion	Vehicle Lotion n=392 participants at risk IDP-123 Vehicle Lotion
General disorders Application Site Pain	5.9% 23/387 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.	0.51% 2/392 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.
Infections and infestations Viral Upper Respiratory Tract Infection	5.2% 20/387 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.	3.8% 15/392 • 12 weeks Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 510-259-5284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER