CompletedNCT02938494Updated Sep 23, 2020Results posted

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

A Phase 2 interventional study of IDP-123 Lotion and Tazorac Cream in Acne Vulgaris, sponsored by Bausch Health Americas, Inc.. Completed at 16 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 210
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Read the detailed description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Conditions studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 730

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 210 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Male or female at least 12 years of age and older.
Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

Key Exclusion Criteria:

Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema.
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
Subjects with a facial beard or mustache that could interfere with the study assessments.
Evidence or history of cosmetic-related acne.
Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 210 participants (actual)

Study arms

Experimental
IDP-123 Lotion
Lotion
Drug: IDP-123 Lotion
Active comparator
Tazorac Cream
Cream
Drug: Tazorac Cream
Active comparator
Vehicle Lotion
Lotion
Drug: Vehicle Lotion
Active comparator
Vehicle Cream
Cream
Drug: Vehicle Cream

Interventions

DrugIDP-123 Lotion
Lotion
Also known as: Lotion
DrugTazorac Cream
Cream
Also known as: Tazorac
DrugVehicle Lotion
Lotion
Also known as: Vehicle
DrugVehicle Cream
Cream
Also known as: Vehicle

What researchers measure

Primary outcomes

Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
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.
Time frame: Baseline (Day 0), Week 12
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
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.
Time frame: Baseline, Week 12
Percentage of Participants With Treatment Success at Week 12
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.
Time frame: Baseline, Week 12

Results

Posted Sep 23, 2020

Participant flow

Participant flow — Overall Study
Milestone	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream
Started	69	72	34	35
Completed	65	63	30	31
Not completed	4	9	4	4

Outcome measures

PrimaryAbsolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12

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.

Time frame:: Baseline (Day 0), Week 12
Reported as:: Mean · lesions

Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
lesions	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12	-21.6 ± 13.98	-20.3 ± 13.67	-13.1 ± 13.62

PrimaryAbsolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12

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.

Time frame:: Baseline, Week 12
Reported as:: Mean · lesions

Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
lesions	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12	-18.1 ± 8.99	-16.8 ± 10.96	-14.0 ± 8.64

PrimaryPercentage of Participants With Treatment Success at Week 12

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.

Time frame:: Baseline, Week 12
Reported as:: Count of participants · Participants

Percentage of Participants With Treatment Success at Week 12
Participants	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Percentage of Participants With Treatment Success at Week 12	13	12	7

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
IDP-123 Lotion	—	0/68 (0%)	2/68 (2.9%)
Tazorac Cream	—	0/71 (0%)	4/71 (5.6%)
Vehicle Lotion	—	0/34 (0%)	1/34 (2.9%)
Vehicle Cream	—	0/33 (0%)	2/33 (6.1%)

Most frequent other events

Most frequent other events
Event	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream
NasopharyngitisInfections and infestations	2/68	4/71	1/34	2/33

Baseline characteristics

Age, Continuous
Age, Continuous(years)	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream	Total
Mean	23.3 ± 10.2	22.0 ± 8.96	21.2 ± 9.27	21.2 ± 7.96	22.2 ± 9.23

Sex: Female, Male
Sex: Female, Male(Participants)	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream	Total
Female	37	41	17	21	116
Male	32	31	17	14	94

Study locations

16 sites

Valeant Site 03
Encinitas, California 92024, United States
Valeant Site 04
Fremont, California 94538, United States
Valeant Site 06
Los Angeles, California 90036, United States
Valeant Site 14
Sacramento, California 95819, United States
Valeant Site 01
Santa Monica, California 90404, United States
Valeant Site 05
Colorado Springs, Colorado 80915, United States
Valeant Site 08
Coral Gables, Florida 33146, United States
Valeant Site 10
Miami, Florida 33175, United States
Valeant Site 09
Miramar, Florida 33027, United States
Valeant Site 12
Louisville, Kentucky 40202, United States
Valeant Site 13
Louisville, Kentucky 40217, United States
Valeant Site 02
Rockville, Maryland 20850, United States
Valeant Site 07
Fridley, Minnesota 55432, United States
Valeant Site 16
Chapel Hill, North Carolina 27517, United States
Valeant Site 15
High Point, North Carolina 27262, United States
Valeant Site 11
Philadelphia, Pennsylvania 19103, United States

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02938494
Lead sponsor: Bausch Health Americas, Inc.
Responsible party: Sponsor
First posted: Oct 19, 2016
Start date: Nov 2015
Primary completion: Jul 2016
Completion: Sep 2016
Results posted: Sep 23, 2020
Last update: Sep 23, 2020

Study contacts

Anya Loncaric

study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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