Trial Outcomes & Findings for Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris (NCT NCT03664739)

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

608 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2023-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	IDP-120 Gel IDP-120 Gel, once daily application	IDP-120 Vehicle Gel IDP-120 Vehicle Gel, once daily application
Overall Study STARTED	306	302
Overall Study COMPLETED	256	270
Overall Study NOT COMPLETED	50	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDP-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application	Total n=606 Participants Total of all reporting groups
Age, Continuous	20.8 years STANDARD_DEVIATION 7.6 • n=5 Participants	20.5 years STANDARD_DEVIATION 7.12 • n=7 Participants	20.6 years STANDARD_DEVIATION 7.36 • n=5 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	194 Participants n=7 Participants	391 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	106 Participants n=7 Participants	215 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	15 Participants n=7 Participants	31 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	75 Participants n=5 Participants	65 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) White	197 Participants n=5 Participants	202 Participants n=7 Participants	399 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Outcome measures
Measure	IDP-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
Absolute Change in Mean Lesion Counts at Week 12 Inflammatory lesions	-18.5 lesion counts Standard Deviation 10.79	-13.3 lesion counts Standard Deviation 9.68
Absolute Change in Mean Lesion Counts at Week 12 Non-inflammatory lesions	-26.3 lesion counts Standard Deviation 15.52	-18.7 lesion counts Standard Deviation 14.28

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-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
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"	41.7 percentage of participants	20.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Outcome measures
Measure	IDP-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
Percentage Change in Mean Lesion Counts at Week 12 Non-inflammatory lesion count	-65.87 percentage change Standard Deviation 37.467	-47.54 percentage change Standard Deviation 33.322
Percentage Change in Mean Lesion Counts at Week 12 Inflammatory lesion count	-66.55 percentage change Standard Deviation 35.017	-48.64 percentage change Standard Deviation 31.910

SECONDARY 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-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)	45.1 percentage of participants	22.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 8

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.

Outcome measures

Outcome measures
Measure	IDP-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
Percentage Change in Mean Lesion Counts at Week 8 Non-inflammatory lesion count	-56.06 percentage change Standard Deviation 34.293	-39.50 percentage change Standard Deviation 33.217
Percentage Change in Mean Lesion Counts at Week 8 Inflammatory lesion count	-60.07 percentage change Standard Deviation 31.620	-41.76 percentage change Standard Deviation 30.710

SECONDARY outcome

Timeframe: Baseline to Week 4

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.

Outcome measures

Outcome measures
Measure	IDP-120 Gel n=306 Participants IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 Participants IDP-120 Vehicle Gel, once daily application
Percentage Change in Mean Lesion Counts at Week 4 Non-inflammatory lesion count	-42.78 percentage change Standard Deviation 32.109	-30.73 percentage change Standard Deviation 31.027
Percentage Change in Mean Lesion Counts at Week 4 Inflammatory lesion count	-47.69 percentage change Standard Deviation 32.010	-35.23 percentage change Standard Deviation 29.951

Adverse Events

IDP-120 Gel

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

IDP-120 Vehicle Gel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IDP-120 Gel n=305 participants at risk IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 participants at risk IDP-120 Vehicle Gel, once daily application
Injury, poisoning and procedural complications Femur fracture	0.33% 1/305 • 12 weeks One subject was excluded from the safety population in the IDP-120 Gel group, due to not applying any study medication.	0.00% 0/300 • 12 weeks One subject was excluded from the safety population in the IDP-120 Gel group, due to not applying any study medication.

Other adverse events

Other adverse events
Measure	IDP-120 Gel n=305 participants at risk IDP-120 Gel, once daily application	IDP-120 Vehicle Gel n=300 participants at risk IDP-120 Vehicle Gel, once daily application
General disorders Application site pain	8.9% 27/305 • 12 weeks One subject was excluded from the safety population in the IDP-120 Gel group, due to not applying any study medication.	1.0% 3/300 • 12 weeks One subject was excluded from the safety population in the IDP-120 Gel group, due to not applying any study medication.

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 19083009920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor for details.
Publication restrictions are in place

Restriction type: OTHER