Trial Outcomes & Findings for Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel (NCT NCT04892706)

NCT ID: NCT04892706

Last Updated: 2025-10-30

Results Overview

Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 686 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2025-10-30

Participant Flow

Participant milestones

Measure	IDP-126 Gel IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel Epiduo® Forte Gel: Gel applied to face once daily in the evening.
Overall Study STARTED	230	228	228
Overall Study COMPLETED	201	196	182
Overall Study NOT COMPLETED	29	32	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel

Baseline characteristics by cohort

Measure	IDP-126 Gel n=230 Participants IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel n=228 Participants IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel n=226 Participants Epiduo® Forte Gel: Gel applied to face once daily in the evening.	Total n=684 Participants Total of all reporting groups
Age, Continuous	17.5 years n=5 Participants	17 years n=7 Participants	18 years n=5 Participants	17 years n=4 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	131 Participants n=7 Participants	135 Participants n=5 Participants	406 Participants n=4 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	97 Participants n=7 Participants	91 Participants n=5 Participants	278 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	27 Participants n=7 Participants	19 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants	78 Participants n=4 Participants
Race (NIH/OMB) White	179 Participants n=5 Participants	160 Participants n=7 Participants	165 Participants n=5 Participants	504 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Baseline Evaluator's Global Severity Score Moderate	201 Participants n=5 Participants	204 Participants n=7 Participants	198 Participants n=5 Participants	603 Participants n=4 Participants
Baseline Evaluator's Global Severity Score Severe	29 Participants n=5 Participants	24 Participants n=7 Participants	28 Participants n=5 Participants	81 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.

Outcome measures

Measure	IDP-126 Gel n=230 Participants IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel n=228 Participants IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel n=226 Participants Epiduo® Forte Gel: Gel applied to face once daily in the evening.
Absolute Change From Baseline to Week 12 in Lesion Counts.	-29.9 lesion counts Standard Deviation 11.43	-19.7 lesion counts Standard Deviation 13.11	-27.9 lesion counts Standard Deviation 12.16

PRIMARY outcome

Timeframe: Baseline to 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=230 Participants IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel n=228 Participants IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel n=226 Participants Epiduo® Forte Gel: Gel applied to face once daily in the evening.
Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.	118 participants	41 participants	74 participants

Adverse Events

IDP-126 Gel

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

IDP-126 Vehicle Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epiduo® Forte Gel

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	IDP-126 Gel n=230 participants at risk IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel n=228 participants at risk IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel n=226 participants at risk Epiduo® Forte Gel: Gel applied to face once daily in the evening.
Injury, poisoning and procedural complications Motor Vehicle Accident	0.43% 1/230 • Number of events 1 • 12 weeks	0.00% 0/228 • 12 weeks	0.00% 0/226 • 12 weeks

Other adverse events

Measure	IDP-126 Gel n=230 participants at risk IDP-126 Gel: Gel applied to face once daily in the evening.	IDP-126 Vehicle Gel n=228 participants at risk IDP-126 Vehicle Gel: Gel applied to face once daily in the evening.	Epiduo® Forte Gel n=226 participants at risk Epiduo® Forte Gel: Gel applied to face once daily in the evening.
General disorders Application Site Pain	10.0% 23/230 • Number of events 23 • 12 weeks	0.00% 0/228 • 12 weeks	7.1% 16/226 • Number of events 16 • 12 weeks

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 908-541-8664

Email: alison.magnotti-nagel@bauschhealth.com

Results disclosure agreements

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

Restriction type: OTHER