Trial Outcomes & Findings for Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris (NCT NCT02938494)

Results Overview

Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

210 participants

Primary outcome timeframe

Baseline (Day 0), Week 12

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	IDP-123 Lotion Lotion IDP-123 Lotion: Lotion	Tazorac Cream Cream Tazorac Cream: Cream	Vehicle Lotion Lotion Vehicle Lotion: Lotion	Vehicle Cream Cream Vehicle Cream: Cream
Overall Study STARTED	69	72	34	35
Overall Study COMPLETED	65	63	30	31
Overall Study NOT COMPLETED	4	9	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDP-123 Lotion n=69 Participants Lotion IDP-123 Lotion: Lotion	Tazorac Cream n=72 Participants Cream Tazorac Cream: Cream	Vehicle Lotion n=34 Participants Lotion Vehicle Lotion: Lotion	Vehicle Cream n=35 Participants Cream Vehicle Cream: Cream	Total n=210 Participants Total of all reporting groups
Age, Continuous	23.3 years STANDARD_DEVIATION 10.2 • n=5 Participants	22.0 years STANDARD_DEVIATION 8.96 • n=7 Participants	21.2 years STANDARD_DEVIATION 9.27 • n=5 Participants	21.2 years STANDARD_DEVIATION 7.96 • n=4 Participants	22.2 years STANDARD_DEVIATION 9.23 • n=21 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	41 Participants n=7 Participants	17 Participants n=5 Participants	21 Participants n=4 Participants	116 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	94 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Week 12

Population: Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.

Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=69 Participants 0.045% tazarotene	Tazorac Cream n=72 Participants Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined n=69 Participants Vehicle Lotion and Vehicle Cream Combined
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12	-21.6 lesions Standard Deviation 13.98	-20.3 lesions Standard Deviation 13.67	-13.1 lesions Standard Deviation 13.62

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.

Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=69 Participants 0.045% tazarotene	Tazorac Cream n=72 Participants Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined n=69 Participants Vehicle Lotion and Vehicle Cream Combined
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12	-18.1 lesions Standard Deviation 8.99	-16.8 lesions Standard Deviation 10.96	-14.0 lesions Standard Deviation 8.64

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.

Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Outcome measures

Outcome measures
Measure	IDP-123 Lotion n=69 Participants 0.045% tazarotene	Tazorac Cream n=72 Participants Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined n=69 Participants Vehicle Lotion and Vehicle Cream Combined
Percentage of Participants With Treatment Success at Week 12	13 Participants	12 Participants	7 Participants

Adverse Events

IDP-123 Lotion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tazorac Cream

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vehicle Lotion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IDP-123 Lotion n=68 participants at risk Lotion IDP-123 Lotion: Lotion	Tazorac Cream n=71 participants at risk Cream Tazorac Cream: Cream	Vehicle Lotion n=34 participants at risk Lotion Vehicle Lotion: Lotion	Vehicle Cream n=33 participants at risk Cream Vehicle Cream: Cream
Infections and infestations Nasopharyngitis	2.9% 2/68 • 12 weeks Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).	5.6% 4/71 • 12 weeks Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).	2.9% 1/34 • 12 weeks Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).	6.1% 2/33 • 12 weeks Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER