A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03168321
• Collaborator: (none)
• Enrollment: 813
• Locations: 45
• Arms: 2
• Actual Duration (Months): 11.3
• Patients Per Site: 18.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This is a multicenter, 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: 813 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: Jun 29, 2017
• Actual Primary Completion Date: Jun 7, 2018
• Actual Study Completion Date: Jun 7, 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 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 19	Phoenix	Arizona	United States	85032
2	Valeant Site 21	Phoenix	Arizona	United States	85032
3	Valeant Site 24	Hot Springs	Arkansas	United States	71913
4	Valeant Site 04	La Mesa	California	United States	91942
5	Valeant Site 02	Manhattan Beach	California	United States	90266
6	Valeant Site 42	Murrieta	California	United States	92562
7	Valeant Site 39	Sacramento	California	United States	95819
8	Valeant Site 01	San Diego	California	United States	22434
9	Valeant Site 37	Wheat Ridge	Colorado	United States	80033
10	Valeant Site 35	Boca Raton	Florida	United States	33486
11	Valeant Site 40	North Miami Beach	Florida	United States	33162
12	Valeant Site 33	Ormond Beach	Florida	United States	32174
13	Valeant Site 27	Pembroke Pines	Florida	United States	33028
14	Valeant Site 13	Sanford	Florida	United States	32771
15	Valeant Site 03	West Palm Beach	Florida	United States	33401
16	Valeant Site 26	Newnan	Georgia	United States	30263
17	Valeant Site 30	Boise	Idaho	United States	83704
18	Valeant Site 06	Arlington Heights	Illinois	United States	60005
19	Valeant Site 23	New Albany	Indiana	United States	47150
20	Valeant Site 17	South Bend	Indiana	United States	46617
21	Valeant Site 31	Overland Park	Kansas	United States	66215
22	Valeant Site 22	Louisville	Kentucky	United States	40217
23	Valeant Site 08	Metairie	Louisiana	United States	70006
24	Valeant Site 38	Detroit	Michigan	United States	48202
25	Valeant Site 16	Warren	Michigan	United States	48088
26	Valeant site 20	New York	New York	United States	10022
27	Valeant Site 36	New York	New York	United States	10075
28	Valeant Site 09	High Point	North Carolina	United States	27262
29	Valeant Site 32	Cincinnati	Ohio	United States	45236
30	Valeant Site 11	Dublin	Ohio	United States	43016
31	valeant Site 07	Gresham	Oregon	United States	97030
32	Valeant Site 15	Johnston	Rhode Island	United States	02919
33	Valeant Site 34	Knoxville	Tennessee	United States	37917
34	valeant Site 14	Nashville	Tennessee	United States	37215
35	Valeant Site 12	Austin	Texas	United States	78759
36	Valeant Site 05	Katy	Texas	United States	77494
37	Valeant Site 18	Plano	Texas	United States	75093
38	Valeant Site 25	San Antonio	Texas	United States	78213
39	Valeant Site 43	Webster	Texas	United States	77598
40	Valeant Site 41	Salt Lake City	Utah	United States	84114
41	Valeant Site 45	Norfolk	Virginia	United States	23507
42	Valeant Site 44	Spokane	Washington	United States	99202
43	Valeant Site 29	Peterborough	Ontario	Canada	K9J5K2
44	Valeant Site 28	Waterloo	Ontario	Canada	N2J1C4
45	Valeant Site 10	Laval	Quebec	Canada	H7E0E3

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: NCT03168321
• Other Study ID Numbers: V01-123A-301
• 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	402	411
COMPLETED	347	356
NOT COMPLETED	55	55

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	402	411	813
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.8 (7.29)	20.4 (6.94)	20.6 (7.11)
Sex: Female, Male (Count of Participants)
Female	280 69.7%	271 65.9%	551 67.8%
Male	122 30.3%	140 34.1%	262 32.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.7%	3 0.7%	6 0.7%
Asian	15 3.7%	13 3.2%	28 3.4%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.5%	2 0.2%
Black or African American	76 18.9%	83 20.2%	159 19.6%
White	293 72.9%	297 72.3%	590 72.6%
More than one race	11 2.7%	10 2.4%	21 2.6%
Unknown or Not Reported	4 1%	3 0.7%	7 0.9%
Lesion counts (lesions) [Mean (Standard Deviation) ]
Non-inflammatory lesions	41.1 (15.67)	40.7 (16.29)	40.9 (15.98)
Inflammatory lesions	28.5 (7.04)	28.1 (7.04)	28.3 (7.04)
Evaluator's Global Severity Score (Count of Participants)
Moderate	368 91.5%	384 93.4%	752 92.5%
Severe	34 8.5%	27 6.6%	61 7.5%

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	402	411
Non-inflammatory lesions	-21.0 (14.72)	-16.4 (14.52)
Inflammatory lesions	-15.6 (10.41)	-12.4 (10.43)

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	402	411
Number [percentage of participants]	25.5 6.3%	13.0 3.2%

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	402	411
Non-inflammatory lesions	-51.36 (36.397)	41.47 (35.223)
Inflammatory lesions	-55.52 (36.531)	-45.70 (36.984)

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	402	411
Number [percentage of participants]	28.3 7%	15.2 3.7%

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	402	411
Non-inflammatory lesions	-43.08 (32.430)	-34.34 (31.684)
Inflammatory lesions	-45.30 (34.351)	-38.96 (34.548)

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	402	411
Non-inflammatory lesions	-29.43 (32.441)	-23.25 (31.817)
Inflammatory lesions	-27.27 (34.980)	-29.70 (34.368)

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	0/392 (0%)		0/399 (0%)
Serious Adverse Events
	IDP-123 Lotion		Vehicle Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/392 (0.8%)		3/399 (0.8%)
Infections and infestations
Appendicitis	0/392 (0%)		1/399 (0.3%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	0/392 (0%)		1/399 (0.3%)
Psychiatric disorders
Suicidal ideation	1/392 (0.3%)		0/399 (0%)
Surgical and medical procedures
Abortion induced	1/392 (0.3%)		1/399 (0.3%)
Abortion spontaneous	1/392 (0.3%)		0/399 (0%)
Other (Not Including Serious) Adverse Events
	IDP-123 Lotion		Vehicle Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/392 (0%)		0/399 (0%)

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.