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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02938494
• Collaborator: (none)
• Enrollment: 210
• Locations: 16
• Arms: 4
• Duration (Months): 10
• Patients Per Site: 13.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-123 Lotion; Drug: Tazorac Cream; Drug: Vehicle Lotion; Drug: Vehicle Cream	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, in the Treatment of Acne Vulgaris
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDP-123 Lotion Lotion	Drug: IDP-123 Lotion; Lotion; Other Names: Lotion
Active Comparator: Tazorac Cream Cream	Drug: Tazorac Cream; Cream; Other Names: Tazorac
Active Comparator: Vehicle Lotion Lotion	Drug: Vehicle Lotion; Lotion; Other Names: Vehicle
Active Comparator: Vehicle Cream Cream	Drug: Vehicle Cream; Cream; Other Names: Vehicle

Outcome Measures

Primary Outcome Measures

1. Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 [Baseline (Day 0), 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.

2. Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 [Baseline, 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.

3. Percentage of Participants With Treatment Success at Week 12 [Baseline, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Valeant Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02938494
• Other Study ID Numbers: V01-123A-201
• First Posted: Oct 19, 2016
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Acne Vulgaris; Tazarotene

Study Results

Participant Flow

Arm/Group Title	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream
Arm/Group Description	Lotion IDP-123 Lotion: Lotion	Cream Tazorac Cream: Cream	Lotion Vehicle Lotion: Lotion	Cream Vehicle Cream: Cream
Period Title: Overall Study
STARTED	69	72	34	35
COMPLETED	65	63	30	31
NOT COMPLETED	4	9	4	4

Baseline Characteristics

Arm/Group Title	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion	Vehicle Cream	Total
Arm/Group Description	Lotion IDP-123 Lotion: Lotion	Cream Tazorac Cream: Cream	Lotion Vehicle Lotion: Lotion	Cream Vehicle Cream: Cream	Total of all reporting groups
Overall Participants	69	72	34	35	210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.3 (10.2)	22.0 (8.96)	21.2 (9.27)	21.2 (7.96)	22.2 (9.23)
Sex: Female, Male (Count of Participants)
Female	37 53.6%	41 56.9%	17 50%	21 60%	116 55.2%
Male	32 46.4%	31 43.1%	17 50%	14 40%	94 44.8%

Outcome Measures

1. Primary Outcome

Title	Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Arm/Group Description	0.045% tazarotene	Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined
Measure Participants	69	72	69
Mean (Standard Deviation) [lesions]	-21.6 (13.98)	-20.3 (13.67)	-13.1 (13.62)

2. Primary Outcome

Title	Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Arm/Group Description	0.045% tazarotene	Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined
Measure Participants	69	72	69
Mean (Standard Deviation) [lesions]	-18.1 (8.99)	-16.8 (10.96)	-14.0 (8.64)

3. Primary Outcome

Title	Percentage of Participants With Treatment Success at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	IDP-123 Lotion	Tazorac Cream	Vehicle Lotion and Vehicle Cream Combined
Arm/Group Description	0.045% tazarotene	Tazorac Cream 0.1%	Vehicle Lotion and Vehicle Cream Combined
Measure Participants	69	72	69
Count of Participants [Participants]	13 18.8%	12 16.7%	7 20.6%

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).
Arm/Group Title	IDP-123 Lotion		Tazorac Cream		Vehicle Lotion		Vehicle Cream
Arm/Group Description	Lotion IDP-123 Lotion: Lotion		Cream Tazorac Cream: Cream		Lotion Vehicle Lotion: Lotion		Cream Vehicle Cream: Cream
All Cause Mortality
	IDP-123 Lotion		Tazorac Cream		Vehicle Lotion		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	IDP-123 Lotion		Tazorac Cream		Vehicle Lotion		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/71 (0%)		0/34 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	IDP-123 Lotion		Tazorac Cream		Vehicle Lotion		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/68 (2.9%)		4/71 (5.6%)		1/34 (2.9%)		2/33 (6.1%)
Infections and infestations
Nasopharyngitis	2/68 (2.9%)		4/71 (5.6%)		1/34 (2.9%)		2/33 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.