Acne Vulgaris
Conditions
Brief summary
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
Detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. 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-123 Lotion
Tazarotene 0.045% Lotion
Vehicle Lotion
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 99 Years
Healthy volunteers
No
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 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-123 Lotion IDP-123 (Tazarotene 0.045%) Lotion | 397 |
| Vehicle Lotion IDP-123 Vehicle Lotion | 404 |
| Total | 801 |
Baseline characteristics
| Characteristic | Vehicle Lotion | IDP-123 Lotion | Total |
|---|---|---|---|
| Age, Continuous | 20.5 years STANDARD_DEVIATION 6.81 | 20.1 years STANDARD_DEVIATION 6.48 | 20.3 years STANDARD_DEVIATION 6.65 |
| Evaluator's Global Severity Score Moderate | 357 Participants | 358 Participants | 715 Participants |
| Evaluator's Global Severity Score Severe | 47 Participants | 39 Participants | 86 Participants |
| Lesion counts Inflammatory lesions | 27.9 lesions STANDARD_DEVIATION 7.1 | 28.0 lesions STANDARD_DEVIATION 7.32 | 28.0 lesions STANDARD_DEVIATION 7.21 |
| Lesion counts Non-inflammatory lesions | 40.6 lesions STANDARD_DEVIATION 16.31 | 41.8 lesions STANDARD_DEVIATION 17.87 | 41.2 lesions STANDARD_DEVIATION 17.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 27 Participants | 50 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 49 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) White | 303 Participants | 298 Participants | 601 Participants |
| Sex: Female, Male Female | 262 Participants | 251 Participants | 513 Participants |
| Sex: Female, Male Male | 142 Participants | 146 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 387 | 0 / 392 |
| other Total, other adverse events | 43 / 387 | 17 / 392 |
| serious Total, serious adverse events | 1 / 387 | 1 / 392 |
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-123 Lotion | Absolute Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesions | -24.6 lesion counts | Standard Deviation 15.33 |
| IDP-123 Lotion | Absolute Change in Mean Lesion Counts at Week 12 | Inflammatory lesions | -16.7 lesion counts | Standard Deviation 9.49 |
| Vehicle Lotion | Absolute Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesions | -16.6 lesion counts | Standard Deviation 15.48 |
| Vehicle Lotion | Absolute Change in Mean Lesion Counts at Week 12 | Inflammatory lesions | -13.4 lesion counts | Standard Deviation 9.37 |
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-123 Lotion | 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 | 29.6 percentage of participants |
| Vehicle Lotion | 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 | 17.3 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-123 Lotion | Percentage Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesions | -60.00 percentage change | Standard Deviation 34.68 |
| IDP-123 Lotion | Percentage Change in Mean Lesion Counts at Week 12 | Inflammatory lesions | -59.50 percentage change | Standard Deviation 33.382 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 12 | Non-inflammatory lesions | -41.58 percentage change | Standard Deviation 35.239 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 12 | Inflammatory lesions | -48.95 percentage change | Standard Deviation 32.898 |
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-123 Lotion | Percentage Change in Mean Lesion Counts at Week 4 | Non-inflammatory lesions | -35.03 percentage change | Standard Deviation 32.776 |
| IDP-123 Lotion | Percentage Change in Mean Lesion Counts at Week 4 | Inflammatory lesions | -32.31 percentage change | Standard Deviation 32.906 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 4 | Non-inflammatory lesions | -24.12 percentage change | Standard Deviation 33.04 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 4 | Inflammatory lesions | -31.55 percentage change | Standard Deviation 32.954 |
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-123 Lotion | Percentage Change in Mean Lesion Counts at Week 8 | Non-inflammatory lesions | -48.45 percentage change | Standard Deviation 36.497 |
| IDP-123 Lotion | Percentage Change in Mean Lesion Counts at Week 8 | Inflammatory lesions | -50.38 percentage change | Standard Deviation 32.917 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 8 | Non-inflammatory lesions | -30.92 percentage change | Standard Deviation 36.772 |
| Vehicle Lotion | Percentage Change in Mean Lesion Counts at Week 8 | Inflammatory lesions | -41.66 percentage change | Standard Deviation 32.874 |
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-123 Lotion | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | 34.5 percentage of participants |
| Vehicle Lotion | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | 20.9 percentage of participants |