Acne Vulgaris
Conditions
Brief summary
study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel
Detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne
Interventions
DRUGIDP-120 Gel
IDP-120 Gel, once-daily application
IDP-120 Vehicle Gel, once-daily application
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Intervention model description
Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female at least 9 years of age and older; 2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit; 4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; 5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; 6. Subjects with two or fewer facial nodules
Exclusion criteria
1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema; 3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. Subjects with a facial beard or mustache that could interfere with the study assessments; 5. Subjects with more than two (2) facial nodules; 6. Evidence or history of cosmetic-related acne
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Mean Lesion Counts at Week 12 | Baseline to Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. |
| Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to Clear or Almost Clear | Baseline to Week 12 | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Mean Lesion Counts at Week 12 | Baseline to Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. |
| Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | Baseline to Week 12 | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. |
| Percentage Change in Mean Lesion Counts at Week 8 | Baseline to Week 8 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. |
| Percentage Change in Mean Lesion Counts at Week 4 | Baseline to Week 4 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-120 Gel IDP-120 Gel, once-daily application | 293 |
| IDP-120 Vehicle Gel IDP-120 Vehicle Gel, once-daily application | 292 |
| Total | 585 |
Baseline characteristics
| Characteristic | IDP-120 Vehicle Gel | Total | IDP-120 Gel |
|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 7.59 | 20.5 years STANDARD_DEVIATION 7.98 | 20.8 years STANDARD_DEVIATION 8.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 28 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 78 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 215 Participants | 444 Participants | 229 Participants |
| Sex: Female, Male Female | 181 Participants | 359 Participants | 178 Participants |
| Sex: Female, Male Male | 111 Participants | 226 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 293 | 0 / 292 |
| other Total, other adverse events | 53 / 293 | 8 / 292 |
| serious Total, serious adverse events | 1 / 293 | 2 / 292 |
Outcome results
Primary
Absolute Change in Mean Lesion Counts at Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-120 Gel | Absolute Change in Mean Lesion Counts at Week 12 | Inflammatory lesion count | -18.5 lesion counts | Standard Deviation 9.5 |
| IDP-120 Gel | Absolute Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesion count | -26.9 lesion counts | Standard Deviation 14.71 |
| IDP-120 Vehicle Gel | Absolute Change in Mean Lesion Counts at Week 12 | Inflammatory lesion count | -13.8 lesion counts | Standard Deviation 9.8 |
| IDP-120 Vehicle Gel | Absolute Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesion count | -16.7 lesion counts | Standard Deviation 15.26 |
Primary
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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-120 Gel | 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 | 33.2 percentage of participants |
| IDP-120 Vehicle Gel | 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 | 14.2 percentage of participants |
Secondary
Percentage Change in Mean Lesion Counts at Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesion count | -61.82 percentage change | Standard Deviation 34.013 |
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 12 | Inflammatory lesion count | -64.88 percentage change | Standard Deviation 32.929 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesion count | -39.01 percentage change | Standard Deviation 35.025 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 12 | Inflammatory lesion count | -49.17 percentage change | Standard Deviation 34.002 |
Secondary
Percentage Change in Mean Lesion Counts at Week 4
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time frame: Baseline to Week 4
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 4 | Non-inflammatory lesion count | -41.15 percentage change | Standard Deviation 32.86 |
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 4 | Inflammatory lesion count | -45.06 percentage change | Standard Deviation 32.313 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 4 | Non-inflammatory lesion count | -23.15 percentage change | Standard Deviation 34.548 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 4 | Inflammatory lesion count | -31.37 percentage change | Standard Deviation 33.789 |
Secondary
Percentage Change in Mean Lesion Counts at Week 8
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Time frame: Baseline to Week 8
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 8 | Non-inflammatory lesion count | -52.41 percentage change | Standard Deviation 35.796 |
| IDP-120 Gel | Percentage Change in Mean Lesion Counts at Week 8 | Inflammatory lesion count | -55.48 percentage change | Standard Deviation 32.992 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 8 | Non-inflammatory lesion count | -28.61 percentage change | Standard Deviation 37.772 |
| IDP-120 Vehicle Gel | Percentage Change in Mean Lesion Counts at Week 8 | Inflammatory lesion count | -38.42 percentage change | Standard Deviation 34.413 |
Secondary
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-120 Gel | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | 36.8 percentage of participants |
| IDP-120 Vehicle Gel | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | 16.7 percentage of participants |