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

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ClinicalTrials.gov Identifier: NCT03168334
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: IDP-123 Lotion
Drug: IDP-123 Vehicle Lotion
Enrollment 801
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide 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
Arm/Group Title IDP-123 Lotion Vehicle Lotion Total
Hide Arm/Group Description IDP-123 (Tazarotene 0.045%) Lotion IDP-123 Vehicle Lotion Total of all reporting groups
Overall Number of Baseline Participants 397 404 801
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 397 participants 404 participants 801 participants
20.1  (6.48) 20.5  (6.81) 20.3  (6.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 404 participants 801 participants
Female
251
  63.2%
262
  64.9%
513
  64.0%
Male
146
  36.8%
142
  35.1%
288
  36.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 404 participants 801 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
   0.0%
2
   0.5%
2
   0.2%
Black or African American
49
  12.3%
54
  13.4%
103
  12.9%
White
298
  75.1%
303
  75.0%
601
  75.0%
More than one race
8
   2.0%
7
   1.7%
15
   1.9%
Unknown or Not Reported
9
   2.3%
12
   3.0%
21
   2.6%
Lesion counts   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 397 participants 404 participants 801 participants
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)
[1]
Measure 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.
Evaluator's Global Severity Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 404 participants 801 participants
Moderate
358
  90.2%
357
  88.4%
715
  89.3%
Severe
39
   9.8%
47
  11.6%
86
  10.7%
[1]
Measure 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.
1.Primary Outcome
Title Absolute Change in Mean Lesion Counts at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Least Squares Mean (Standard Deviation)
Unit of Measure: lesion counts
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"
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Measure Type: Number
Unit of Measure: percentage of participants
29.6 17.3
3.Secondary Outcome
Title Percentage Change in Mean Lesion Counts at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Least Squares Mean (Standard Deviation)
Unit of Measure: percentage change
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Measure Type: Number
Unit of Measure: percentage of participants
34.5 20.9
5.Secondary Outcome
Title Percentage Change in Mean Lesion Counts at Week 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Least Squares Mean (Standard Deviation)
Unit of Measure: percentage change
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-123 Lotion Vehicle Lotion
Hide Arm/Group Description:
IDP-123 (Tazarotene 0.045%) Lotion
IDP-123 Vehicle Lotion
Overall Number of Participants Analyzed 397 404
Least Squares Mean (Standard Deviation)
Unit of Measure: percentage change
Non-inflammatory lesions -35.03  (32.776) -24.12  (33.040)
Inflammatory lesions -32.31  (32.906) -31.55  (32.954)
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
Hide Arm/Group Description IDP-123 (Tazarotene 0.045%) Lotion IDP-123 Vehicle Lotion
All-Cause Mortality
IDP-123 Lotion Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/387 (0.00%)   0/392 (0.00%) 
Hide Serious Adverse Events
IDP-123 Lotion Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   1/387 (0.26%)   1/392 (0.26%) 
Psychiatric disorders     
Suicidal ideation * 1  0/387 (0.00%)  1/392 (0.26%) 
Surgical and medical procedures     
Abortion induced * 1  1/387 (0.26%)  0/392 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDP-123 Lotion Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   43/387 (11.11%)   17/392 (4.34%) 
General disorders     
Application Site Pain * 1  23/387 (5.94%)  2/392 (0.51%) 
Infections and infestations     
Viral Upper Respiratory Tract Infection * 1  20/387 (5.17%)  15/392 (3.83%) 
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Please contact Sponsor directly for additional information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Bausch Health Americas, Inc
Phone: 510-259-5284
EMail: aloncaric@bauschhealth.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03168334    
Other Study ID Numbers: V01-123A-302
First Submitted: May 24, 2017
First Posted: May 30, 2017
Results First Submitted: February 15, 2021
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021