Acne Vulgaris
Conditions
Brief summary
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Detailed description
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Interventions
Vehicle Gel
DRUGIDP-126 Gel
Gel
DRUGIDP-126 Component A
Component A
DRUGIDP-126 Component B
Component B
DRUGIDP-126 Component C
Component C
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. 4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100. 5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150. 6. Subjects with 2 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 2 facial nodules. 6. Evidence or history of cosmetic-related acne.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesion Counts | Baseline to Week 12 | Absolute change from Baseline to Week 12 in mean inflammatory lesion counts |
| Non-inflammatory Lesion Counts | Baseline to Week 12 | Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts |
| Percentage of Participants With Success on the Evaluator's Global Severity Score | Baseline to Week 12 | Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Baseline to Week 2, 4, 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts |
| Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Baseline to Week 2, 4, 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts |
| Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Baseline to Week 2, 4, and 8 | Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
| Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Baseline to Week 2, 4, and 8 | Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
| Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Baseline to Week 2, 4, 8 | Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts |
| Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Baseline to Week 2, 4, 8 | Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-126 Gel Gel
IDP-126 Gel: Gel | 146 |
| IDP-126 Component A Component A
IDP-126 Component A: Component A | 150 |
| IDP-126 Component B Component B
IDP-126 Component B: Component B | 146 |
| IDP-126 Component C Component C
IDP-126 Component C: Component C | 150 |
| IDP-126 Vehicle Gel Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel | 148 |
| Total | 740 |
Baseline characteristics
| Characteristic | IDP-126 Gel | IDP-126 Component A | IDP-126 Component B | IDP-126 Component C | IDP-126 Vehicle Gel | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 17 years | 17 years | 17 years | 17 years | 17 years | 17 years |
| Baseline Evaluator's Global Severity Score Moderate | 124 Participants | 119 Participants | 124 Participants | 129 Participants | 127 Participants | 623 Participants |
| Baseline Evaluator's Global Severity Score Severe | 22 Participants | 31 Participants | 22 Participants | 21 Participants | 21 Participants | 117 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 6 Participants | 8 Participants | 9 Participants | 17 Participants | 50 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 26 Participants | 30 Participants | 20 Participants | 26 Participants | 126 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 4 Participants | 6 Participants | 10 Participants | 8 Participants | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 98 Participants | 109 Participants | 101 Participants | 109 Participants | 95 Participants | 512 Participants |
| Sex: Female, Male Female | 94 Participants | 86 Participants | 91 Participants | 93 Participants | 89 Participants | 453 Participants |
| Sex: Female, Male Male | 52 Participants | 64 Participants | 55 Participants | 57 Participants | 59 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 0 / 146 | 0 / 144 | 0 / 148 | 0 / 146 |
| other Total, other adverse events | 30 / 141 | 29 / 146 | 6 / 144 | 19 / 148 | 7 / 146 |
| serious Total, serious adverse events | 1 / 141 | 0 / 146 | 0 / 144 | 3 / 148 | 0 / 146 |
Outcome results
Primary
Inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Time frame: Baseline to Week 12
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDP-126 Gel | Inflammatory Lesion Counts | -29.9 lesions | Standard Deviation 11.86 |
| IDP-126 Component A | Inflammatory Lesion Counts | -26.7 lesions | Standard Deviation 11.74 |
| IDP-126 Component B | Inflammatory Lesion Counts | -24.8 lesions | Standard Deviation 11.71 |
| IDP-126 Component C | Inflammatory Lesion Counts | -26.8 lesions | Standard Deviation 11.69 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Counts | -19.6 lesions | Standard Deviation 12.12 |
Primary
Non-inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Time frame: Baseline to Week 12
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDP-126 Gel | Non-inflammatory Lesion Counts | -35.5 lesions | Standard Deviation 16.25 |
| IDP-126 Component A | Non-inflammatory Lesion Counts | -29.9 lesions | Standard Deviation 16.4 |
| IDP-126 Component B | Non-inflammatory Lesion Counts | -27.8 lesions | Standard Deviation 15.97 |
| IDP-126 Component C | Non-inflammatory Lesion Counts | -30.0 lesions | Standard Deviation 16.4 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Counts | -21.8 lesions | Standard Deviation 16.58 |
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.
Time frame: Baseline to Week 12
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-126 Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score | 52.5 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Success on the Evaluator's Global Severity Score | 27.8 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Success on the Evaluator's Global Severity Score | 30.5 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Success on the Evaluator's Global Severity Score | 30.3 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score | 8.1 percentage of participants |
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
Time frame: Baseline to Week 2, 4, 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-126 Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -14.0 lesions | Standard Deviation 11.62 |
| IDP-126 Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -25.8 lesions | Standard Deviation 11.97 |
| IDP-126 Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -21.0 lesions | Standard Deviation 10.33 |
| IDP-126 Component A | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -17.1 lesions | Standard Deviation 12.07 |
| IDP-126 Component A | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -11.8 lesions | Standard Deviation 10.8 |
| IDP-126 Component A | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -23.0 lesions | Standard Deviation 11.69 |
| IDP-126 Component B | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -18.8 lesions | Standard Deviation 12.05 |
| IDP-126 Component B | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -13.8 lesions | Standard Deviation 10.5 |
| IDP-126 Component B | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -23.1 lesions | Standard Deviation 13.95 |
| IDP-126 Component C | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -13.4 lesions | Standard Deviation 10.76 |
| IDP-126 Component C | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -22.8 lesions | Standard Deviation 9.86 |
| IDP-126 Component C | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -17.7 lesions | Standard Deviation 11.49 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -14.8 lesions | Standard Deviation 10.26 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -9.2 lesions | Standard Deviation 9.58 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -17.5 lesions | Standard Deviation 10.86 |
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
Time frame: Baseline to Week 2, 4, 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-126 Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -35.89 percentage change | Standard Deviation 29.073 |
| IDP-126 Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -66.07 percentage change | Standard Deviation 22.239 |
| IDP-126 Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -54.42 percentage change | Standard Deviation 22.683 |
| IDP-126 Component A | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -44.37 percentage change | Standard Deviation 28.511 |
| IDP-126 Component A | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -30.27 percentage change | Standard Deviation 26.417 |
| IDP-126 Component A | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -59.07 percentage change | Standard Deviation 25.573 |
| IDP-126 Component B | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -47.55 percentage change | Standard Deviation 28.04 |
| IDP-126 Component B | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -35.10 percentage change | Standard Deviation 26.442 |
| IDP-126 Component B | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -59.55 percentage change | Standard Deviation 31.99 |
| IDP-126 Component C | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -35.23 percentage change | Standard Deviation 26.926 |
| IDP-126 Component C | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -60.10 percentage change | Standard Deviation 23.863 |
| IDP-126 Component C | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -46.32 percentage change | Standard Deviation 27.664 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -39.95 percentage change | Standard Deviation 27.304 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -24.18 percentage change | Standard Deviation 26 |
| IDP-126 Vehicle Gel | Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -46.61 percentage change | Standard Deviation 27.495 |
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
Time frame: Baseline to Week 2, 4, 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-126 Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -12.9 lesions | Standard Deviation 12.9 |
| IDP-126 Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -30.5 lesions | Standard Deviation 15.95 |
| IDP-126 Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -21.4 lesions | Standard Deviation 14.33 |
| IDP-126 Component A | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -18.6 lesions | Standard Deviation 13.74 |
| IDP-126 Component A | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -11.0 lesions | Standard Deviation 14.31 |
| IDP-126 Component A | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -25.1 lesions | Standard Deviation 15.43 |
| IDP-126 Component B | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -15.8 lesions | Standard Deviation 13.77 |
| IDP-126 Component B | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -11.2 lesions | Standard Deviation 10.97 |
| IDP-126 Component B | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -21.7 lesions | Standard Deviation 16.08 |
| IDP-126 Component C | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -11.3 lesions | Standard Deviation 14.02 |
| IDP-126 Component C | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -26.8 lesions | Standard Deviation 14.68 |
| IDP-126 Component C | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -18.0 lesions | Standard Deviation 14.35 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 4 | -13.7 lesions | Standard Deviation 11.78 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 2 | -9.2 lesions | Standard Deviation 11.94 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 | Week 8 | -17.6 lesions | Standard Deviation 15.29 |
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
Time frame: Baseline to Week 2, 4, 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDP-126 Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -27.07 percentage change | Standard Deviation 26.44 |
| IDP-126 Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -60.05 percentage change | Standard Deviation 25.164 |
| IDP-126 Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -43.17 percentage change | Standard Deviation 27.162 |
| IDP-126 Component A | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -39.28 percentage change | Standard Deviation 26.422 |
| IDP-126 Component A | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -23.39 percentage change | Standard Deviation 30.433 |
| IDP-126 Component A | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -52.76 percentage change | Standard Deviation 27.916 |
| IDP-126 Component B | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -23.72 percentage change | Standard Deviation 22.845 |
| IDP-126 Component B | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -33.84 percentage change | Standard Deviation 29.592 |
| IDP-126 Component B | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -47.29 percentage change | Standard Deviation 32.982 |
| IDP-126 Component C | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -24.91 percentage change | Standard Deviation 28.698 |
| IDP-126 Component C | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -54.17 percentage change | Standard Deviation 26.53 |
| IDP-126 Component C | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -38.14 percentage change | Standard Deviation 27.765 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 4 | -29.53 percentage change | Standard Deviation 26.025 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 2 | -19.68 percentage change | Standard Deviation 23.194 |
| IDP-126 Vehicle Gel | Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 | Week 8 | -37.84 percentage change | Standard Deviation 29.933 |
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.
Time frame: Baseline to Week 2, 4, and 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-126 Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 2 | 1.49 percentage of participants |
| IDP-126 Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 8 | 20.46 percentage of participants |
| IDP-126 Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 4 | 8.17 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 4 | 6.77 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 2 | 1.35 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 8 | 15.97 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 4 | 2.79 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 2 | 0.71 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 8 | 15.26 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 2 | 2.68 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 8 | 15.75 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 4 | 4.27 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 4 | 1.36 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 2 | 0.00 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 | Week 8 | 3.51 percentage of participants |
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.
Time frame: Baseline to Week 2, 4, and 8
Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-126 Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 2 | 2.95 percentage of participants |
| IDP-126 Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 8 | 28.74 percentage of participants |
| IDP-126 Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 4 | 11.46 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 4 | 10.53 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 2 | 2.78 percentage of participants |
| IDP-126 Component A | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 8 | 22.79 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 4 | 5.83 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 2 | 1.45 percentage of participants |
| IDP-126 Component B | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 8 | 19.97 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 2 | 5.44 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 8 | 20.66 percentage of participants |
| IDP-126 Component C | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 4 | 8.51 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 4 | 2.12 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 2 | 1.36 percentage of participants |
| IDP-126 Vehicle Gel | Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 | Week 8 | 4.43 percentage of participants |