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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-126 Gel | Experimental | Gel |
|
| IDP-126 Component A | Active Comparator | Component A |
|
| IDP-126 Component B | Active Comparator | Component B |
|
| IDP-126 Component C | Active Comparator | Component C |
|
| IDP-126 Vehicle Gel | Placebo Comparator | Vehicle Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-126 Gel | Drug | Gel |
| |
| IDP-126 Component A |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean inflammatory lesion counts | Baseline to Week 12 |
| Non-inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts | Baseline to Week 12 |
| Percentage of Participants With Success on the Evaluator's Global Severity Score | 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | Baseline to Week 2, 4, 8 |
| Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 02 | Hot Springs | Arkansas | 71913 | United States | ||
| Valeant Site 07 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40377868 | Derived | Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L. Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. Dermatol Ther (Heidelb). 2025 Jul;15(7):1867-1882. doi: 10.1007/s13555-025-01440-z. Epub 2025 May 16. | |
| 34674160 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-126 Gel | Gel IDP-126 Gel: Gel |
| FG001 | IDP-126 Component A | Component A IDP-126 Component A: Component A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2017 |
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Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
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| Drug |
Component A |
|
| IDP-126 Component B | Drug | Component B |
|
| IDP-126 Component C | Drug | Component C |
|
| IDP-126 Vehicle Gel | Drug | Vehicle Gel |
|
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
| Baseline to Week 2, 4, 8 |
| Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | Baseline to Week 2, 4, 8 |
| Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts | Baseline to Week 2, 4, 8 |
| Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 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. | Baseline to Week 2, 4, and 8 |
| Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 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. | Baseline to Week 2, 4, and 8 |
| Fremont |
| California |
| 94538 |
| United States |
| Valeant Site 08 | Sacramento | California | 95819 | United States |
| Valeant Site 09 | Denver | Colorado | 80220 | United States |
| Valeant Site 11 | Boynton Beach | Florida | 33437 | United States |
| Valeant Site 13 | North Miami Beach | Florida | 33162 | United States |
| Valeant Site 12 | Sanford | Florida | 32771 | United States |
| Valeant Site 10 | West Palm Beach | Florida | 33401 | United States |
| Valeant Site 15 | Marietta | Georgia | 30060 | United States |
| Valeant Site 14 | Snellville | Georgia | 30078 | United States |
| Valeant Site 16 | Boise | Idaho | 83704 | United States |
| Valeant Site 17 | Overland Park | Kansas | 66215 | United States |
| Valeant Site 18 | Louisville | Kentucky | 40217 | United States |
| Valeant Site 19 | Louisville | Kentucky | 40241 | United States |
| valeant Site 21 | Glenn Dale | Maryland | 20769 | United States |
| Valeant Site 20 | Needham | Massachusetts | 02492 | United States |
| Valeant Site 22 | Detroit | Michigan | 48202 | United States |
| Valeant Site 24 | Morristown | New Jersey | 07960 | United States |
| Valeant Site 25 | Albuquerque | New Mexico | 87106 | United States |
| Valeant Site 27 | New York | New York | 10022 | United States |
| Valeant Site 26 | New York | New York | 10075 | United States |
| Valeant Site 23 | High Point | North Carolina | 27262 | United States |
| Valeant Site 28 | Gresham | Oregon | 97030 | United States |
| Valeant Site 30 | Johnston | Rhode Island | 02919 | United States |
| Valeant Site 31 | Nashville | Tennessee | 37215 | United States |
| Valeant Site 32 | Austin | Texas | 78759 | United States |
| Valeant Site 33 | Pflugerville | Texas | 78660 | United States |
| valeant Site 34 | San Antonio | Texas | 78213 | United States |
| Valeant Site 35 | Norfolk | Virginia | 23502 | United States |
| Valeant Site 01 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Valeant Site 05 | Barrie | Ontario | L4M7G1 | Canada |
| Valeant Site 06 | Oakville | Ontario | L6J7W5 | Canada |
| Valeant Site 04 | Peterborough | Ontario | K9J5K2 | Canada |
| Valeant Site 03 | Waterloo | Ontario | N2J1C4 | Canada |
| Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21. |
| FG002 |
| IDP-126 Component B |
Component B IDP-126 Component B: Component B |
| FG003 | IDP-126 Component C | Component C IDP-126 Component C: Component C |
| FG004 | IDP-126 Vehicle Gel | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| COMPLETED |
|
| NOT COMPLETED |
|
One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-126 Gel | Gel IDP-126 Gel: Gel |
| BG001 | IDP-126 Component A | Component A IDP-126 Component A: Component A |
| BG002 | IDP-126 Component B | Component B IDP-126 Component B: Component B |
| BG003 | IDP-126 Component C | Component C IDP-126 Component C: Component C |
| BG004 | IDP-126 Vehicle Gel | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Evaluator's Global Severity Score | 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. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Least Squares Mean | Standard Deviation | lesions | Baseline to Week 12 |
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| Primary | Non-inflammatory Lesion Counts | Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Least Squares Mean | Standard Deviation | lesions | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Success on the Evaluator's Global Severity Score | 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. | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Number | percentage of participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Mean | Standard Deviation | lesions | Baseline to Week 2, 4, 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Mean | Standard Deviation | lesions | Baseline to Week 2, 4, 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Mean | Standard Deviation | percentage change | Baseline to Week 2, 4, 8 |
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| Secondary | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Mean | Standard Deviation | percentage change | Baseline to Week 2, 4, 8 |
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| Secondary | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 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. | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Number | percentage of participants | Baseline to Week 2, 4, and 8 |
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| Secondary | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 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. | One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population. | Posted | Number | percentage of participants | Baseline to Week 2, 4, and 8 |
|
12 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDP-126 Gel | Gel IDP-126 Gel: Gel | 0 | 141 | 1 | 141 | 30 | 141 |
| EG001 | IDP-126 Component A | Component A IDP-126 Component A: Component A | 0 | 146 | 0 | 146 | 29 | 146 |
| EG002 | IDP-126 Component B | Component B IDP-126 Component B: Component B | 0 | 144 | 0 | 144 | 6 | 144 |
| EG003 | IDP-126 Component C | Component C IDP-126 Component C: Component C | 0 | 148 | 3 | 148 | 19 | 148 |
| EG004 | IDP-126 Vehicle Gel | Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel | 0 | 146 | 0 | 146 | 7 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anemia with crisis | Blood and lymphatic system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Application Site Dryness | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
Please contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 5102595284 | aloncaric@bauschhealth.com |
| Sep 17, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Severe |
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| IDP-126 Vehicle Gel |
Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
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Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
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| OG004 |
| IDP-126 Vehicle Gel |
Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
|
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| OG004 |
| IDP-126 Vehicle Gel |
Vehicle Gel IDP-126 Vehicle Gel: Vehicle Gel |
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|