A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03170388
Collaborator
(none)
741
34
5
18.6
21.8
1.2
Study Details
Study Description
Brief Summary
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Study Design
Study Type:
Interventional
Actual Enrollment
:
741 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-GroupMulticenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Actual Study Start Date
:
Oct 5, 2017
Actual Primary Completion Date
:
Apr 23, 2019
Actual Study Completion Date
:
Apr 23, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IDP-126 Gel Gel |
Drug: IDP-126 Gel
Gel
|
| Active Comparator: IDP-126 Component A Component A |
Drug: IDP-126 Component A
Component A
|
| Active Comparator: IDP-126 Component B Component B |
Drug: IDP-126 Component B
Component B
|
| Active Comparator: IDP-126 Component C Component C |
Drug: IDP-126 Component C
Component C
|
| Placebo Comparator: IDP-126 Vehicle Gel Vehicle Gel |
Drug: IDP-126 Vehicle Gel
Vehicle Gel
|
Outcome Measures
Primary Outcome Measures
- Inflammatory Lesion Counts [Baseline to Week 12]
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
- Non-inflammatory Lesion Counts [Baseline to Week 12]
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
- Percentage of Participants With Success on the Evaluator's Global Severity Score [Baseline to Week 12]
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Secondary Outcome Measures
- Inflammatory Lesion Count Changes at Week 2, 4, and 8 [Baseline to Week 2, 4, 8]
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
- Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 [Baseline to Week 2, 4, 8]
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
- Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 [Baseline to Week 2, 4, 8]
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
- Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 [Baseline to Week 2, 4, 8]
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
- Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 [Baseline to Week 2, 4, and 8]
Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
- Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 [Baseline to Week 2, 4, and 8]
Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female at least 9 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).
-
Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
-
Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
-
Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
-
Subjects with 2 or fewer facial nodules
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, gram negative 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.
-
Subjects with more than 2 facial nodules.
-
Evidence or history of cosmetic-related acne.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valeant Site 02 | Hot Springs | Arkansas | United States | 71913 |
| 2 | Valeant Site 07 | Fremont | California | United States | 94538 |
| 3 | Valeant Site 08 | Sacramento | California | United States | 95819 |
| 4 | Valeant Site 09 | Denver | Colorado | United States | 80220 |
| 5 | Valeant Site 11 | Boynton Beach | Florida | United States | 33437 |
| 6 | Valeant Site 13 | North Miami Beach | Florida | United States | 33162 |
| 7 | Valeant Site 12 | Sanford | Florida | United States | 32771 |
| 8 | Valeant Site 10 | West Palm Beach | Florida | United States | 33401 |
| 9 | Valeant Site 15 | Marietta | Georgia | United States | 30060 |
| 10 | Valeant Site 14 | Snellville | Georgia | United States | 30078 |
| 11 | Valeant Site 16 | Boise | Idaho | United States | 83704 |
| 12 | Valeant Site 17 | Overland Park | Kansas | United States | 66215 |
| 13 | Valeant Site 18 | Louisville | Kentucky | United States | 40217 |
| 14 | Valeant Site 19 | Louisville | Kentucky | United States | 40241 |
| 15 | valeant Site 21 | Glenn Dale | Maryland | United States | 20769 |
| 16 | Valeant Site 20 | Needham | Massachusetts | United States | 02492 |
| 17 | Valeant Site 22 | Detroit | Michigan | United States | 48202 |
| 18 | Valeant Site 24 | Morristown | New Jersey | United States | 07960 |
| 19 | Valeant Site 25 | Albuquerque | New Mexico | United States | 87106 |
| 20 | Valeant Site 27 | New York | New York | United States | 10022 |
| 21 | Valeant Site 26 | New York | New York | United States | 10075 |
| 22 | Valeant Site 23 | High Point | North Carolina | United States | 27262 |
| 23 | Valeant Site 28 | Gresham | Oregon | United States | 97030 |
| 24 | Valeant Site 30 | Johnston | Rhode Island | United States | 02919 |
| 25 | Valeant Site 31 | Nashville | Tennessee | United States | 37215 |
| 26 | Valeant Site 32 | Austin | Texas | United States | 78759 |
| 27 | Valeant Site 33 | Pflugerville | Texas | United States | 78660 |
| 28 | valeant Site 34 | San Antonio | Texas | United States | 78213 |
| 29 | Valeant Site 35 | Norfolk | Virginia | United States | 23502 |
| 30 | Valeant Site 01 | Winnipeg | Manitoba | Canada | R3M 3Z4 |
| 31 | Valeant Site 05 | Barrie | Ontario | Canada | L4M7G1 |
| 32 | Valeant Site 06 | Oakville | Ontario | Canada | L6J7W5 |
| 33 | Valeant Site 04 | Peterborough | Ontario | Canada | K9J5K2 |
| 34 | Valeant Site 03 | Waterloo | Ontario | Canada | N2J1C4 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Anya Loncaric, Bausch Health Americas, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT03170388
Other Study ID Numbers:
- V01-126A-201
First Posted:
May 31, 2017
Last Update Posted:
Nov 10, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Period Title: Overall Study | |||||
| STARTED | 147 | 150 | 146 | 150 | 148 |
| COMPLETED | 125 | 132 | 133 | 132 | 127 |
| NOT COMPLETED | 22 | 18 | 13 | 18 | 21 |
Baseline Characteristics
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel | Total of all reporting groups |
| Overall Participants | 146 | 150 | 146 | 150 | 148 | 740 |
| Age (years) [Median (Full Range) ] | ||||||
| Median (Full Range) [years] |
17
|
17
|
17
|
17
|
17
|
17
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
94
64.4%
|
86
57.3%
|
91
62.3%
|
93
62%
|
89
60.1%
|
453
61.2%
|
| Male |
52
35.6%
|
64
42.7%
|
55
37.7%
|
57
38%
|
59
39.9%
|
287
38.8%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
1
0.7%
|
1
0.7%
|
1
0.7%
|
1
0.7%
|
2
1.4%
|
6
0.8%
|
| Asian |
10
6.8%
|
6
4%
|
8
5.5%
|
9
6%
|
17
11.5%
|
50
6.8%
|
| Native Hawaiian or Other Pacific Islander |
2
1.4%
|
4
2.7%
|
0
0%
|
1
0.7%
|
0
0%
|
7
0.9%
|
| Black or African American |
24
16.4%
|
26
17.3%
|
30
20.5%
|
20
13.3%
|
26
17.6%
|
126
17%
|
| White |
98
67.1%
|
109
72.7%
|
101
69.2%
|
109
72.7%
|
95
64.2%
|
512
69.2%
|
| More than one race |
11
7.5%
|
4
2.7%
|
6
4.1%
|
10
6.7%
|
8
5.4%
|
39
5.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Baseline Evaluator's Global Severity Score (Count of Participants) | ||||||
| Moderate |
124
84.9%
|
119
79.3%
|
124
84.9%
|
129
86%
|
127
85.8%
|
623
84.2%
|
| Severe |
22
15.1%
|
31
20.7%
|
22
15.1%
|
21
14%
|
21
14.2%
|
117
15.8%
|
Outcome Measures
| Title | Inflammatory Lesion Counts |
|---|---|
| Description | Absolute change from Baseline to Week 12 in mean inflammatory lesion counts |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Least Squares Mean (Standard Deviation) [lesions] |
-29.9
(11.86)
|
-26.7
(11.74)
|
-24.8
(11.71)
|
-26.8
(11.69)
|
-19.6
(12.12)
|
| Title | Non-inflammatory Lesion Counts |
|---|---|
| Description | Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Least Squares Mean (Standard Deviation) [lesions] |
-35.5
(16.25)
|
-29.9
(16.40)
|
-27.8
(15.97)
|
-30.0
(16.40)
|
-21.8
(16.58)
|
| Title | Percentage of Participants With Success on the Evaluator's Global Severity Score |
|---|---|
| Description | Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Number [percentage of participants] |
52.5
36%
|
27.8
18.5%
|
30.5
20.9%
|
30.3
20.2%
|
8.1
5.5%
|
| Title | Inflammatory Lesion Count Changes at Week 2, 4, and 8 |
|---|---|
| Description | Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts |
| Time Frame | Baseline to Week 2, 4, 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
-14.0
(11.62)
|
-11.8
(10.80)
|
-13.8
(10.50)
|
-13.4
(10.76)
|
-9.2
(9.58)
|
| Week 4 |
-21.0
(10.33)
|
-17.1
(12.07)
|
-18.8
(12.05)
|
-17.7
(11.49)
|
-14.8
(10.26)
|
| Week 8 |
-25.8
(11.97)
|
-23.0
(11.69)
|
-23.1
(13.95)
|
-22.8
(9.86)
|
-17.5
(10.86)
|
| Title | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 |
|---|---|
| Description | Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts |
| Time Frame | Baseline to Week 2, 4, 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
-12.9
(12.90)
|
-11.0
(14.31)
|
-11.2
(10.97)
|
-11.3
(14.02)
|
-9.2
(11.94)
|
| Week 4 |
-21.4
(14.33)
|
-18.6
(13.74)
|
-15.8
(13.77)
|
-18.0
(14.35)
|
-13.7
(11.78)
|
| Week 8 |
-30.5
(15.95)
|
-25.1
(15.43)
|
-21.7
(16.08)
|
-26.8
(14.68)
|
-17.6
(15.29)
|
| Title | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 |
|---|---|
| Description | Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts |
| Time Frame | Baseline to Week 2, 4, 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
-35.89
(29.073)
|
-30.27
(26.417)
|
-35.10
(26.442)
|
-35.23
(26.926)
|
-24.18
(26.000)
|
| Week 4 |
-54.42
(22.683)
|
-44.37
(28.511)
|
-47.55
(28.040)
|
-46.32
(27.664)
|
-39.95
(27.304)
|
| Week 8 |
-66.07
(22.239)
|
-59.07
(25.573)
|
-59.55
(31.990)
|
-60.10
(23.863)
|
-46.61
(27.495)
|
| Title | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 |
|---|---|
| Description | Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts |
| Time Frame | Baseline to Week 2, 4, 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
-27.07
(26.440)
|
-23.39
(30.433)
|
-23.72
(22.845)
|
-24.91
(28.698)
|
-19.68
(23.194)
|
| Week 4 |
-43.17
(27.162)
|
-39.28
(26.422)
|
-33.84
(29.592)
|
-38.14
(27.765)
|
-29.53
(26.025)
|
| Week 8 |
-60.05
(25.164)
|
-52.76
(27.916)
|
-47.29
(32.982)
|
-54.17
(26.530)
|
-37.84
(29.933)
|
| Title | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 |
|---|---|
| Description | Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
| Time Frame | Baseline to Week 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
1.49
1%
|
1.35
0.9%
|
0.71
0.5%
|
2.68
1.8%
|
0.00
0%
|
| Week 4 |
8.17
5.6%
|
6.77
4.5%
|
2.79
1.9%
|
4.27
2.8%
|
1.36
0.9%
|
| Week 8 |
20.46
14%
|
15.97
10.6%
|
15.26
10.5%
|
15.75
10.5%
|
3.51
2.4%
|
| Title | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 |
|---|---|
| Description | Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
| Time Frame | Baseline to Week 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. |
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel |
|---|---|---|---|---|---|
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| Measure Participants | 146 | 150 | 146 | 150 | 148 |
| Week 2 |
2.95
2%
|
2.78
1.9%
|
1.45
1%
|
5.44
3.6%
|
1.36
0.9%
|
| Week 4 |
11.46
7.8%
|
10.53
7%
|
5.83
4%
|
8.51
5.7%
|
2.12
1.4%
|
| Week 8 |
28.74
19.7%
|
22.79
15.2%
|
19.97
13.7%
|
20.66
13.8%
|
4.43
3%
|
Adverse Events
| Time Frame | 12 weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations. | |||||||||
| Arm/Group Title | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | |||||
| Arm/Group Description | Gel IDP-126 Gel: Gel | Component A IDP-126 Component A: Component A | Component B IDP-126 Component B: Component B | Component C IDP-126 Component C: Component C | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel | |||||
All Cause Mortality |
||||||||||
| IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/141 (0%) | 0/146 (0%) | 0/144 (0%) | 0/148 (0%) | 0/146 (0%) | |||||
Serious Adverse Events |
||||||||||
| IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/141 (0.7%) | 0/146 (0%) | 0/144 (0%) | 3/148 (2%) | 0/146 (0%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Sickle cell anemia with crisis | 1/141 (0.7%) | 0/146 (0%) | 0/144 (0%) | 0/148 (0%) | 0/146 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Enteritis | 0/141 (0%) | 0/146 (0%) | 0/144 (0%) | 1/148 (0.7%) | 0/146 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hyperbilirubinemia | 0/141 (0%) | 0/146 (0%) | 0/144 (0%) | 1/148 (0.7%) | 0/146 (0%) | |||||
| Surgical and medical procedures | ||||||||||
| Abortion induced | 0/141 (0%) | 0/146 (0%) | 0/144 (0%) | 1/148 (0.7%) | 0/146 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/141 (21.3%) | 29/146 (19.9%) | 6/144 (4.2%) | 19/148 (12.8%) | 7/146 (4.8%) | |||||
| General disorders | ||||||||||
| Application Site Pain | 11/141 (7.8%) | 16/146 (11%) | 1/144 (0.7%) | 5/148 (3.4%) | 1/146 (0.7%) | |||||
| Application Site Dryness | 9/141 (6.4%) | 8/146 (5.5%) | 2/144 (1.4%) | 9/148 (6.1%) | 1/146 (0.7%) | |||||
| Infections and infestations | ||||||||||
| Viral Upper Respiratory Tract Infection | 10/141 (7.1%) | 5/146 (3.4%) | 3/144 (2.1%) | 5/148 (3.4%) | 5/146 (3.4%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Please contact sponsor for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health Americas, Inc |
| Phone | 5102595284 |
| aloncaric@bauschhealth.com |
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT03170388
Other Study ID Numbers:
- V01-126A-201
First Posted:
May 31, 2017
Last Update Posted:
Nov 10, 2021
Last Verified:
Oct 1, 2021