Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, knee, topical therapy, pain
Brief summary
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee. Each patient's participation is approximately 7 weeks (\ 1 week screening, 4 weeks of treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1. Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain in their daily diary, as well as to document all study drug applications and any rescue medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and within approximately 2 weeks after the last study drug application for end-of-study evaluations.
Interventions
DRUGG001 Topical Gel
Non-steroidal anti-inflammatory drug for topical administration
DRUGVehicle
Vehicle Gel for topical administration
Sponsors
Veristat, Inc.
BUZZZ Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of OA of the knee, meeting American College of Rheumatology (ACR) criteria for classification of idiopathic (primary) OA for at least 6 months prior to Screening * Radiologic evidence of OA of the knee of grade 2 (mild) or grade 3 (moderate) according to Kellgren and Lawrence Radiographic Grading * Worst daily pain (within 24 hours prior to Screening and Baseline) in the index knee between 4 and 8 on the 11-point pain NRS * On stable analgesic therapy At Baseline: \- Development of a flare of pain following washout of stable analgesic (NSAID and/or acetaminophen) therapy
Exclusion criteria
* Radiologic evidence of severe OA of the knee (Kellgren and Lawrence grade 4) * Secondary OA of the index knee * Any other arthritis, included but not limited to rheumatoid arthritis, psoriatic arthritis, etc. * History of pseudo-gout or inflammatory flare-ups * History of severe neurological conditions * Any other chronic pain conditions (e.g., back pain) or disabling conditions affecting the joints * Patients who are non-ambulatory or require the use of crutches or a walker, or started using a cane within 30 days prior to Screening * Any history of major surgery to the index knee, minor knee surgery, or injury to the index knee within 1 year prior to Screening * Knee arthroscopy (index knee) within 3 months prior to Screening * Planned or candidate for knee replacement or knee reconstruction surgery * Received intra-articular viscosupplementation/hyaluronate, joint lavage, or other invasive therapies to the index knee in the past 90 days * Treatment with or need for any of the following: (1) oral or intramuscular corticosteroids within the past 90 days; (2) intra-articular corticosteroid injection into the index knee within the past 90 days, or into any other joint within the past 30 days; (3) current use of topical corticosteroids on the index knee * Prior stable therapy with an opioid analgesic, or anticipated need for opioid analgesic use during the study * Use of sedative hypnotic medication, antidepressants with known analgesic effect, antipsychotics, antiepileptics, and anti-Parkinson drugs within the past 14 days * Regular use of medication for headaches * Anticipated use of any oral or topical NSAID (apart from the study drug) during the study * Known sensitivity to the study drug (or any of its ingredients), or NSAIDs, or presence of contraindications, warnings, or precautions At Baseline: * Worst daily pain (within the past 24 hours) in the contralateral knee assessed as \>2 on the 11-point pain NRS scale * Non-compliance with the daily diary requirement during the Screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT | Week 4 | Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT | Week 4 | WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome) |
| Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | Week 4 to Week 5 | Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) |
| Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | Weeks 2, 4 and 5 | PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened |
| Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | Weeks 2, 4 and 5 | IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened |
| PGA of Overall Treatment Benefit (OTB) | Weeks 2 and 4 | PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. |
| IGA of Overall Treatment Benefit (OTB) | Weeks 2 and 4 | IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. |
| Rescue Medication Use | 5 weeks | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. |
| Number of Rescue Medication Doses | 5 weeks | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. |
| Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings | Week 4 | Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome |
| Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings | Week 4 | Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome |
| Percent Reduction From Baseline in Worst Daytime Pain | Week 4 | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT |
| Percent Reduction From Baseline in Worst Nighttime Pain | Week 4 | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT |
| Change From Baseline in WOMAC Total Score at Week 4/EOT | Week 4 | WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) |
| Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT | Week 4 | WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome) |
| Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | Week 2 | Change from Baseline to Week 2 in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Weeks 2, 4, and 6 | The Numerical Total Score is the sum of the Dermal Response score (from 0=No evidence of irritation to 7=Strong reaction spreading beyond the application site) and the numeric equivalent of Other Effects score (from 0=Slightly glazed appearance to 3=Small petechial erosions and/or scabs). The Numerical Total Score range is from 0 to 10, with higher scores indicating worse outcome/skin irritation. |
| ECG Abnormalities in QT, QTc, QRS, or PR Intervals | 4 weeks | Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT |
| Changes From Baseline in Safety Laboratory Test Results | 6 weeks | Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges |
| Changes in Vital Signs Measurements | 6 weeks | Mean changes (descriptive) from baseline |
| Changes in Physical Examination | 6 weeks | Number and percentage of participants with clinically significant abnormal findings |
| Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | 6 weeks | Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation |
| Frequency and Severity of Application Site AEs | 6 weeks | Number and percentage of participants with application site AEs |
Countries
Canada
Participant flow
Recruitment details
The study was conducted at 10 study centers in Canada. A total of 210 patients with OA of the knee were randomly assigned to double-blinded treatment in the study; of these, 105 patients received G001 and 105 patients received Vehicle.
Pre-assignment details
Following screening, prior NSAID and/or acetaminophen use was discontinued to allow for washout (3 to 7 days) and symptom flare. Eligible patients with adequate OA pain in the index knee were randomly assigned to G001 or Vehicle in a 1:1 allocation ratio.
Participants by arm
| Arm | Count |
|---|---|
| G001 Topical Gel G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
G001 Topical Gel: Non-steroidal anti-inflammatory drug for topical administration | 105 |
| Vehicle Topical Gel Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration | 105 |
| Total | 210 |
Baseline characteristics
| Characteristic | Vehicle Topical Gel | Total | G001 Topical Gel |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 8.35 | 64.8 years STANDARD_DEVIATION 8.12 | 64.3 years STANDARD_DEVIATION 7.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 209 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Kellgren and Lawrence Grading KL Grade 2 | 53 Participants | 99 Participants | 46 Participants |
| Kellgren and Lawrence Grading KL Grade 3 | 52 Participants | 111 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 27 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 89 Participants | 172 Participants | 83 Participants |
| Region of Enrollment Canada | 105 participants | 210 participants | 105 participants |
| Sex: Female, Male Female | 61 Participants | 125 Participants | 64 Participants |
| Sex: Female, Male Male | 44 Participants | 85 Participants | 41 Participants |
| Worst daily pain (11-point NRS), Contralateral knee | 0.9 Score on a scale STANDARD_DEVIATION 0.81 | 1.0 Score on a scale STANDARD_DEVIATION 0.8 | 1.1 Score on a scale STANDARD_DEVIATION 0.78 |
| Worst daily pain (11-point NRS), Index knee | 6.4 Score on a scale STANDARD_DEVIATION 1.39 | 6.6 Score on a scale STANDARD_DEVIATION 1.35 | 6.8 Score on a scale STANDARD_DEVIATION 1.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 10 / 105 | 5 / 105 |
| serious Total, serious adverse events | 0 / 105 | 1 / 105 |
Outcome results
Primary
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)
Time frame: Week 4
Population: Modified intent-to-treat (mITT) population: All randomized patients who received at least 1 dose of study drug and provided both baseline/Flare Visit 1 (FV1) and Week 4/End-of-Treatment (EOT) efficacy assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT | -5.4 score on a scale | Standard Error 0.32 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT | -5.2 score on a scale | Standard Error 0.32 |
p-value: 0.674295% CI: [-1.081, 0.701]t-test, 2 sided
Secondary
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Time frame: Weeks 2, 4 and 5
Population: mITT Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | No Change | 74 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | Worsened | 1 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | Improved | 39 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | Improved | 30 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | Worsened | 1 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | No Change | 67 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | No Change | 63 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | Worsened | 3 Participants |
| G001 Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | Improved | 24 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | Worsened | 1 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | Improved | 22 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | No Change | 77 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 2 | Worsened | 3 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | Improved | 29 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | No Change | 72 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 4 | Worsened | 3 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | Improved | 21 Participants |
| Vehicle Topical Gel | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of DA, Change from BL to Week 5 | No Change | 78 Participants |
Secondary
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Time frame: Weeks 2, 4 and 5
Population: mITT
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | No change | 74 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | Worsened | 0 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | Improved | 38 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | Improved | 26 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | Worsened | 1 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | No change | 73 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | No change | 64 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | Worsened | 1 Participants |
| G001 Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | Improved | 24 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | Worsened | 4 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | Improved | 20 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | No change | 79 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 2 | Worsened | 3 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | Improved | 28 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | No change | 72 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 4 | Worsened | 4 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | Improved | 21 Participants |
| Vehicle Topical Gel | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of DA, Change from BL to Week 5 | No change | 75 Participants |
Secondary
Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT
WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome)
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT | -12.5 score on a scale | Standard Error 1.07 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT | -10.4 score on a scale | Standard Error 1.06 |
Secondary
Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT
WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome)
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT | -1.6 score on a scale | Standard Error 0.14 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT | -1.5 score on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
Change from Baseline to Week 2 in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)
Time frame: Week 2
Population: mITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| G001 Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Total score, Change from BL to Week 2 | -15.7 score on a scale | Standard Error 1.27 |
| G001 Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Pain score, Change from BL to Week 2 | -4.7 score on a scale | Standard Error 0.29 |
| G001 Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Stiffness score, Change from BL to Week 2 | -1.4 score on a scale | Standard Error 0.13 |
| G001 Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Physical Function score, Change from BL to Week 2 | -9.5 score on a scale | Standard Error 0.93 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Physical Function score, Change from BL to Week 2 | -8.0 score on a scale | Standard Error 0.91 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Total score, Change from BL to Week 2 | -13.2 score on a scale | Standard Error 1.25 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Stiffness score, Change from BL to Week 2 | -1.0 score on a scale | Standard Error 0.13 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | WOMAC Pain score, Change from BL to Week 2 | -4.4 score on a scale | Standard Error 0.29 |
Secondary
Change From Baseline in WOMAC Total Score at Week 4/EOT
WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome)
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Change From Baseline in WOMAC Total Score at Week 4/EOT | -19.4 score on a scale | Standard Error 1.47 |
| Vehicle Topical Gel | Change From Baseline in WOMAC Total Score at Week 4/EOT | -17.1 score on a scale | Standard Error 1.46 |
Secondary
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)
Time frame: Week 4 to Week 5
Population: mITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| G001 Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Total score, Change from Week 4/EOT to Week 5/FV2 | 3.5 score on a scale | Standard Error 0.89 |
| G001 Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Pain score, Change from Week 4/EOT to Week 5/FV2 | 0.8 score on a scale | Standard Error 0.21 |
| G001 Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Stiffness score, Change from Week 4/EOT to Week 5/FV2 | 0.3 score on a scale | Standard Error 0.1 |
| G001 Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Physical Function score, Change from Week 4/EOT to Week 5/FV2 | 2.4 score on a scale | Standard Error 0.65 |
| Vehicle Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Physical Function score, Change from Week 4/EOT to Week 5/FV2 | 1.7 score on a scale | Standard Error 0.65 |
| Vehicle Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Total score, Change from Week 4/EOT to Week 5/FV2 | 2.7 score on a scale | Standard Error 0.89 |
| Vehicle Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Stiffness score, Change from Week 4/EOT to Week 5/FV2 | 0.3 score on a scale | Standard Error 0.1 |
| Vehicle Topical Gel | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | WOMAC Pain score, Change from Week 4/EOT to Week 5/FV2 | 0.7 score on a scale | Standard Error 0.21 |
Secondary
IGA of Overall Treatment Benefit (OTB)
IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.
Time frame: Weeks 2 and 4
Population: mITT Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Very Good or Good | 32 Participants |
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Fair | 47 Participants |
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Poor or Very Poor | 20 Participants |
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Very Good or Good | 52 Participants |
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Fair | 35 Participants |
| G001 Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Poor or Very Poor | 16 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Fair | 39 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Very Good or Good | 40 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Very Good or Good | 46 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Fair | 47 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 4 | Poor or Very Poor | 19 Participants |
| Vehicle Topical Gel | IGA of Overall Treatment Benefit (OTB) | IGA of OTB, Week 2 | Poor or Very Poor | 15 Participants |
Secondary
Number of Rescue Medication Doses
Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.
Time frame: 5 weeks
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Number of Rescue Medication Doses | 5.9 number of doses | Standard Deviation 6.03 |
| Vehicle Topical Gel | Number of Rescue Medication Doses | 7.9 number of doses | Standard Deviation 12.54 |
Secondary
Percent Reduction From Baseline in Worst Daytime Pain
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT
Time frame: Week 4
Population: mITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| G001 Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 20% Reduction from BL | 70 Participants |
| G001 Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 30% Reduction from BL | 58 Participants |
| G001 Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 50% Reduction from BL | 35 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 20% Reduction from BL | 68 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 30% Reduction from BL | 53 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Daytime Pain | ≥ 50% Reduction from BL | 36 Participants |
Secondary
Percent Reduction From Baseline in Worst Nighttime Pain
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| G001 Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 30% Reduction from BL | 59 Participants |
| G001 Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 20% Reduction from BL | 73 Participants |
| G001 Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 50% Reduction from BL | 36 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 20% Reduction from BL | 65 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 30% Reduction from BL | 56 Participants |
| Vehicle Topical Gel | Percent Reduction From Baseline in Worst Nighttime Pain | ≥ 50% Reduction from BL | 35 Participants |
Secondary
PGA of Overall Treatment Benefit (OTB)
PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.
Time frame: Weeks 2 and 4
Population: mITT Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Good or Very Good | 32 Participants |
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Fair | 49 Participants |
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Poor or Very Poor | 18 Participants |
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Good or Very Good | 50 Participants |
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Fair | 36 Participants |
| G001 Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Poor or Very Poor | 16 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Fair | 38 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Good or Very Good | 39 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Good or Very Good | 46 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Fair | 47 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 4 | Poor or Very Poor | 20 Participants |
| Vehicle Topical Gel | PGA of Overall Treatment Benefit (OTB) | PGA of OTB at Week 2 | Poor or Very Poor | 16 Participants |
Secondary
Rescue Medication Use
Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.
Time frame: 5 weeks
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Rescue Medication Use | 71.6 mg/day | Standard Deviation 66.65 |
| Vehicle Topical Gel | Rescue Medication Use | 94.6 mg/day | Standard Deviation 123.3 |
Secondary
Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings
Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings | -2.1 score on a scale | Standard Deviation 2.01 |
| Vehicle Topical Gel | Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings | -2.0 score on a scale | Standard Deviation 2.07 |
Secondary
Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings
Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome
Time frame: Week 4
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G001 Topical Gel | Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings | -2.1 score on a scale | Standard Deviation 2.01 |
| Vehicle Topical Gel | Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings | -1.9 score on a scale | Standard Deviation 2.04 |
Other Pre-specified
Changes From Baseline in Safety Laboratory Test Results
Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges
Time frame: 6 weeks
Other Pre-specified
Changes in Physical Examination
Number and percentage of participants with clinically significant abnormal findings
Time frame: 6 weeks
Other Pre-specified
Changes in Vital Signs Measurements
Mean changes (descriptive) from baseline
Time frame: 6 weeks
Other Pre-specified
ECG Abnormalities in QT, QTc, QRS, or PR Intervals
Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT
Time frame: 4 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| G001 Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QT Interval abnormality | 0 Participants |
| G001 Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QRS Interval abnormality | 0 Participants |
| G001 Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS PR Interval abnormality | 0 Participants |
| G001 Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QTc Interval abnormality | 0 Participants |
| Vehicle Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS PR Interval abnormality | 0 Participants |
| Vehicle Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QT Interval abnormality | 0 Participants |
| Vehicle Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QTc Interval abnormality | 0 Participants |
| Vehicle Topical Gel | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | CS QRS Interval abnormality | 0 Participants |
Other Pre-specified
Frequency and Severity of Application Site AEs
Number and percentage of participants with application site AEs
Time frame: 6 weeks
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| G001 Topical Gel | Frequency and Severity of Application Site AEs | 0 Participants |
| Vehicle Topical Gel | Frequency and Severity of Application Site AEs | 1 Participants |
Other Pre-specified
Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation
Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation
Time frame: 6 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| G001 Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any TEAE | 36 Participants |
| G001 Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Treatment-related TEAEs | 5 Participants |
| G001 Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any SAE | 0 Participants |
| G001 Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any TEAE leading to Discontinuation | 3 Participants |
| Vehicle Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any TEAE leading to Discontinuation | 1 Participants |
| Vehicle Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any TEAE | 28 Participants |
| Vehicle Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Any SAE | 1 Participants |
| Vehicle Topical Gel | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Treatment-related TEAEs | 4 Participants |
Other Pre-specified
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
The Numerical Total Score is the sum of the Dermal Response score (from 0=No evidence of irritation to 7=Strong reaction spreading beyond the application site) and the numeric equivalent of Other Effects score (from 0=Slightly glazed appearance to 3=Small petechial erosions and/or scabs). The Numerical Total Score range is from 0 to 10, with higher scores indicating worse outcome/skin irritation.
Time frame: Weeks 2, 4, and 6
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of 1 | 1 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of ≥2 | 1 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of 0 | 101 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of 0 | 101 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of ≥2 | 1 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of 1 | 0 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of 1 | 1 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of ≥2 | 0 Participants |
| G001 Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of 0 | 98 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of ≥2 | 0 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of 0 | 101 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of 1 | 0 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 2 | Numerical Total Score of ≥2 | 1 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of 0 | 103 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of 1 | 1 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 4/EOT | Numerical Total Score of ≥2 | 0 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of 0 | 101 Participants |
| Vehicle Topical Gel | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | Skin Irritation Total Score, Week 6 | Numerical Total Score of 1 | 0 Participants |