A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03168334
• Collaborator: (none)
• Enrollment: 801
• Locations: 45
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site: 17.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-123 Lotion; Drug: IDP-123 Vehicle Lotion	Phase 3

Detailed Description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Study Design

• Study Type: Interventional
• Actual Enrollment: 801 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris
• Actual Study Start Date: Jul 11, 2017
• Actual Primary Completion Date: Jul 24, 2018
• Actual Study Completion Date: Jul 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDP-123 Lotion Tazarotene 0.045% Lotion	Drug: IDP-123 Lotion; Tazarotene 0.045% Lotion; Other Names: IDP-123
Placebo Comparator: IDP-123 Vehicle Lotion Vehicle Lotion	Drug: IDP-123 Vehicle Lotion; Vehicle Lotion; Other Names: Vehicle

Outcome Measures

Primary Outcome Measures

1. Absolute Change in Mean Lesion Counts at Week 12 [Baseline to Week 12]

   For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

2. Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" [Baseline to Week 12]

   Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

Secondary Outcome Measures

1. Percentage Change in Mean Lesion Counts at Week 12 [Baseline to Week 12]

   For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

2. Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) [Baseline to Week 12]

   Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

3. Percentage Change in Mean Lesion Counts at Week 8 [Baseline to Week 8]

   For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

4. Percentage Change in Mean Lesion Counts at Week 4 [Baseline to Week 4]

   For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female at least 9 years of age and older;

2. 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);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

6. Subjects with two or fewer facial nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;

2. 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, gram-negative folliculitis, dermatitis, eczema;

3. 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;

4. Subjects with a facial beard or mustache that could interfere with the study assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valeant Site 41	Mobile	Alabama	United States	36608
2	Valeant Site 22	Rogers	Arkansas	United States	72758
3	Valeant Site 34	Carlsbad	California	United States	92008
4	Valeant Site 12	Fremont	California	United States	94538
5	Valeant Site 06	San Diego	California	United States	92123
6	Valeant Site 13	San Diego	California	United States	92123
7	Valeant Site 31	San Diego	California	United States	92123
8	Valeant Site 36	Santa Ana	California	United States	92701
9	Valeant Site 25	Denver	Colorado	United States	80220
10	Valeant Site 05	Boynton Beach	Florida	United States	33437
11	Valeant Site 29	Clearwater	Florida	United States	33761
12	Valeant Site 38	Jupiter	Florida	United States	33458
13	Valeant Site 02	Miami	Florida	United States	33144
14	Valeant Site 26	West Palm Beach	Florida	United States	33406
15	Valeant Site 44	Snellville	Georgia	United States	30078
16	Valeant Site 32	Louisville	Kentucky	United States	40241
17	Valeant Site 19	Rockville	Maryland	United States	20850
18	Valeant Site 08	Bay City	Michigan	United States	48706
19	Valeant Site 30	Clarkston	Michigan	United States	48346
20	Valeant Site 37	Clinton Township	Michigan	United States	48038
21	Valeant Site 20	Fort Gratiot	Michigan	United States	48059
22	Valeant Site 24	Fridley	Minnesota	United States	55432
23	Valeant Site 03	Morristown	New Jersey	United States	07960
24	Valeant Site 42	Albuquerque	New Mexico	United States	87106
25	Valeant Site 10	New York	New York	United States	10155
26	Valeant Site 43	Rochester	New York	United States	14623
27	Valeant Site 33	Stony Brook	New York	United States	11790
28	Valeant Site 11	Oklahoma City	Oklahoma	United States	73112
29	Valeant Site 28	Broomall	Pennsylvania	United States	19008
30	Valeant Site 16	Warwick	Rhode Island	United States	02886
31	Valeant Site 18	Knoxville	Tennessee	United States	37922
32	Valeant Site 14	Murfreesboro	Tennessee	United States	37130
33	Valeant Site 23	College Station	Texas	United States	77845
34	Valeant Site 07	Dallas	Texas	United States	75234
35	Valeant Site 27	Pflugerville	Texas	United States	78660
36	Valeant Site 04	San Antonio	Texas	United States	78218
37	Valeant Site 39	Sugar Land	Texas	United States	77479
38	Valeant Site 09	Layton	Utah	United States	84041
39	Valeant Site 15	West Jordan	Utah	United States	84088
40	Valeant Site 21	Charlottesville	Virginia	United States	22911
41	Valeant Site 35	Walla Walla	Washington	United States	99362
42	Valeant Site 01	Surrey	British Columbia	Canada	V3VOC6
43	Valeant Site 45	Winnipeg	Manitoba	Canada	R3M3Z4
44	Valeant Site 40	Windsor	Ontario	Canada	N8W5L7
45	Valeant Site 17	Saint-Jérôme	Quebec	Canada	J7Z3B8

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Valeant Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 24, 2017

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT03168334
• Other Study ID Numbers: V01-123A-302
• First Posted: May 30, 2017
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Period Title: Overall Study
STARTED	397	404
COMPLETED	345	366
NOT COMPLETED	52	38

Baseline Characteristics

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion	Total
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion	Total of all reporting groups
Overall Participants	397	404	801
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.1 (6.48)	20.5 (6.81)	20.3 (6.65)
Sex: Female, Male (Count of Participants)
Female	251 63.2%	262 64.9%	513 64%
Male	146 36.8%	142 35.1%	288 36%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 1.5%	3 0.7%	9 1.1%
Asian	27 6.8%	23 5.7%	50 6.2%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.5%	2 0.2%
Black or African American	49 12.3%	54 13.4%	103 12.9%
White	298 75.1%	303 75%	601 75%
More than one race	8 2%	7 1.7%	15 1.9%
Unknown or Not Reported	9 2.3%	12 3%	21 2.6%
Lesion counts (lesions) [Mean (Standard Deviation) ]
Non-inflammatory lesions	41.8 (17.87)	40.6 (16.31)	41.2 (17.10)
Inflammatory lesions	28.0 (7.32)	27.9 (7.10)	28.0 (7.21)
Evaluator's Global Severity Score (Count of Participants)
Moderate	358 90.2%	357 88.4%	715 89.3%
Severe	39 9.8%	47 11.6%	86 10.7%

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Mean Lesion Counts at Week 12
Description	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Non-inflammatory lesions	-24.6 (15.33)	-16.6 (15.48)
Inflammatory lesions	-16.7 (9.49)	-13.4 (9.37)

2. Primary Outcome

Title	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
Description	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Number [percentage of participants]	29.6 7.5%	17.3 4.3%

3. Secondary Outcome

Title	Percentage Change in Mean Lesion Counts at Week 12
Description	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Non-inflammatory lesions	-60.00 (34.680)	-41.58 (35.239)
Inflammatory lesions	-59.50 (33.382)	-48.95 (32.898)

4. Secondary Outcome

Title	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Description	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Number [percentage of participants]	34.5 8.7%	20.9 5.2%

5. Secondary Outcome

Title	Percentage Change in Mean Lesion Counts at Week 8
Description	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Non-inflammatory lesions	-48.45 (36.497)	-30.92 (36.772)
Inflammatory lesions	-50.38 (32.917)	-41.66 (32.874)

6. Secondary Outcome

Title	Percentage Change in Mean Lesion Counts at Week 4
Description	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IDP-123 Lotion	Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion	IDP-123 Vehicle Lotion
Measure Participants	397	404
Non-inflammatory lesions	-35.03 (32.776)	-24.12 (33.040)
Inflammatory lesions	-32.31 (32.906)	-31.55 (32.954)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.
Arm/Group Title	IDP-123 Lotion		Vehicle Lotion
Arm/Group Description	IDP-123 (Tazarotene 0.045%) Lotion		IDP-123 Vehicle Lotion
All Cause Mortality
	IDP-123 Lotion		Vehicle Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/387 (0%)		0/392 (0%)
Serious Adverse Events
	IDP-123 Lotion		Vehicle Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/387 (0.3%)		1/392 (0.3%)
Psychiatric disorders
Suicidal ideation	0/387 (0%)		1/392 (0.3%)
Surgical and medical procedures
Abortion induced	1/387 (0.3%)		0/392 (0%)
Other (Not Including Serious) Adverse Events
	IDP-123 Lotion		Vehicle Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/387 (11.1%)		17/392 (4.3%)
General disorders
Application Site Pain	23/387 (5.9%)		2/392 (0.5%)
Infections and infestations
Viral Upper Respiratory Tract Infection	20/387 (5.2%)		15/392 (3.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Please contact Sponsor directly for additional information.