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 NCT03664752)

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

585 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	293	292
Overall Study COMPLETED	244	241
Overall Study NOT COMPLETED	49	51

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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 Participants IDP-120 Vehicle Gel, once-daily application	Total n=585 Participants Total of all reporting groups
Age, Continuous	20.8 years STANDARD_DEVIATION 8.35 • n=5 Participants	20.2 years STANDARD_DEVIATION 7.59 • n=7 Participants	20.5 years STANDARD_DEVIATION 7.98 • n=5 Participants
Sex: Female, Male Female	178 Participants n=5 Participants	181 Participants n=7 Participants	359 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	111 Participants n=7 Participants	226 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) White	229 Participants n=5 Participants	215 Participants n=7 Participants	444 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 Participants IDP-120 Vehicle Gel, once-daily application
Absolute Change in Mean Lesion Counts at Week 12 Inflammatory lesion count	-18.5 lesion counts Standard Deviation 9.50	-13.8 lesion counts Standard Deviation 9.80
Absolute Change in Mean Lesion Counts at Week 12 Non-inflammatory lesion count	-26.9 lesion counts Standard Deviation 14.71	-16.7 lesion counts Standard Deviation 15.26

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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 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"	33.2 percentage of participants	14.2 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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 Participants IDP-120 Vehicle Gel, once-daily application
Percentage Change in Mean Lesion Counts at Week 12 Non-inflammatory lesion count	-61.82 percentage change Standard Deviation 34.013	-39.01 percentage change Standard Deviation 35.025
Percentage Change in Mean Lesion Counts at Week 12 Inflammatory lesion count	-64.88 percentage change Standard Deviation 32.929	-49.17 percentage change Standard Deviation 34.002

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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 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)	36.8 percentage of participants	16.7 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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 Participants IDP-120 Vehicle Gel, once-daily application
Percentage Change in Mean Lesion Counts at Week 8 Non-inflammatory lesion count	-52.41 percentage change Standard Deviation 35.796	-28.61 percentage change Standard Deviation 37.772
Percentage Change in Mean Lesion Counts at Week 8 Inflammatory lesion count	-55.48 percentage change Standard Deviation 32.992	-38.42 percentage change Standard Deviation 34.413

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=293 Participants IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 Participants IDP-120 Vehicle Gel, once-daily application
Percentage Change in Mean Lesion Counts at Week 4 Non-inflammatory lesion count	-41.15 percentage change Standard Deviation 32.860	-23.15 percentage change Standard Deviation 34.548
Percentage Change in Mean Lesion Counts at Week 4 Inflammatory lesion count	-45.06 percentage change Standard Deviation 32.313	-31.37 percentage change Standard Deviation 33.789

Adverse Events

IDP-120 Gel

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

IDP-120 Vehicle Gel

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IDP-120 Gel n=293 participants at risk IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 participants at risk IDP-120 Vehicle Gel, once-daily application
Surgical and medical procedures Abortion induced	0.34% 1/293 • 12 weeks	0.00% 0/292 • 12 weeks
Immune system disorders Anaphylactic reaction	0.00% 0/293 • 12 weeks	0.34% 1/292 • 12 weeks
Injury, poisoning and procedural complications Overdose	0.00% 0/293 • 12 weeks	0.34% 1/292 • 12 weeks
Psychiatric disorders Suicide attempt	0.00% 0/293 • 12 weeks	0.34% 1/292 • 12 weeks

Other adverse events

Other adverse events
Measure	IDP-120 Gel n=293 participants at risk IDP-120 Gel, once-daily application	IDP-120 Vehicle Gel n=292 participants at risk IDP-120 Vehicle Gel, once-daily application
General disorders Application site pain	13.3% 39/293 • 12 weeks	2.1% 6/292 • 12 weeks
General disorders Application site dryness	9.2% 27/293 • 12 weeks	1.4% 4/292 • 12 weeks

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