Trial Outcomes & Findings for Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris (NCT NCT04214639)

NCT ID: NCT04214639

Last Updated: 2024-02-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 183 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-02-01

Participant Flow

Participant milestones

Measure	IDP-126 Gel IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Overall Study STARTED	122	61
Overall Study COMPLETED	107	55
Overall Study NOT COMPLETED	15	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Baseline characteristics by cohort

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.	Total n=183 Participants Total of all reporting groups
Age, Continuous	17 years n=5 Participants	18 years n=7 Participants	17 years n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	31 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	30 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	9 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	45 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Baseline Evaluator's Global Severity Score Moderate	107 Participants n=5 Participants	58 Participants n=7 Participants	165 Participants n=5 Participants
Baseline Evaluator's Global Severity Score Severe	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts	-27.7 lesion counts Standard Deviation 9.55	-21.7 lesion counts Standard Deviation 8.79

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	-35.4 lesion counts Standard Deviation 15.52	-23.5 lesion counts Standard Deviation 14.93

PRIMARY outcome

Timeframe: 12 weeks

Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Percentage of Participants With Success on the Evaluator's Global Severity Score	49.6 percentage of participants	24.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 4, 8, 12

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 4	-51.14 percentage change Standard Deviation 26.115	-38.91 percentage change Standard Deviation 25.691
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 8	-63.35 percentage change Standard Deviation 27.793	-50.58 percentage change Standard Deviation 26.569
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 12	-75.70 percentage change Standard Deviation 26.663	-59.62 percentage change Standard Deviation 24.348

SECONDARY outcome

Timeframe: Baseline to Week 4, 8, 12

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 8	-57.92 percentage change Standard Deviation 31.654	-44.70 percentage change Standard Deviation 30.118
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 4	-45.87 percentage change Standard Deviation 28.119	-30.42 percentage change Standard Deviation 27.455
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12 Week 12	-72.70 percentage change Standard Deviation 32.364	-47.61 percentage change Standard Deviation 31.069

SECONDARY outcome

Timeframe: 12 weeks

The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Outcome measures

Measure	IDP-126 Gel n=122 Participants IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 Participants IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	57.2 percentage of participants	24.8 percentage of participants

Adverse Events

IDP-126 Gel

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

IDP-126 Vehicle Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IDP-126 Gel n=122 participants at risk IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	IDP-126 Vehicle Gel n=61 participants at risk IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
General disorders Application site pain	12.3% 15/122 • 12 weeks	0.00% 0/61 • 12 weeks
Skin and subcutaneous tissue disorders Erythema	6.6% 8/122 • 12 weeks	0.00% 0/61 • 12 weeks

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 7072851528

Email: Varsha.Bhatt@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact sponsor for details.
• Publication restrictions are in place

Restriction type: OTHER