Trial Outcomes & Findings for A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301) (NCT NCT03168321)
NCT ID: NCT03168321
Last Updated: 2021-04-01
Results Overview
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.
COMPLETED
PHASE3
813 participants
Baseline to Week 12
2021-04-01
Participant Flow
Participant milestones
| Measure |
IDP-123 Lotion
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Overall Study
STARTED
|
402
|
411
|
|
Overall Study
COMPLETED
|
347
|
356
|
|
Overall Study
NOT COMPLETED
|
55
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Baseline characteristics by cohort
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 Vehicle Lotion
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.8 years
STANDARD_DEVIATION 7.29 • n=99 Participants
|
20.4 years
STANDARD_DEVIATION 6.94 • n=107 Participants
|
20.6 years
STANDARD_DEVIATION 7.11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
280 Participants
n=99 Participants
|
271 Participants
n=107 Participants
|
551 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
293 Participants
n=99 Participants
|
297 Participants
n=107 Participants
|
590 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Lesion counts
Non-inflammatory lesions
|
41.1 lesions
STANDARD_DEVIATION 15.67 • n=99 Participants
|
40.7 lesions
STANDARD_DEVIATION 16.29 • n=107 Participants
|
40.9 lesions
STANDARD_DEVIATION 15.98 • n=206 Participants
|
|
Lesion counts
Inflammatory lesions
|
28.5 lesions
STANDARD_DEVIATION 7.04 • n=99 Participants
|
28.1 lesions
STANDARD_DEVIATION 7.04 • n=107 Participants
|
28.3 lesions
STANDARD_DEVIATION 7.04 • n=206 Participants
|
|
Evaluator's Global Severity Score
Moderate
|
368 Participants
n=99 Participants
|
384 Participants
n=107 Participants
|
752 Participants
n=206 Participants
|
|
Evaluator's Global Severity Score
Severe
|
34 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12For 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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Absolute Change in Mean Lesion Counts at Week 12
Non-inflammatory lesions
|
-21.0 lesion counts
Standard Deviation 14.72
|
-16.4 lesion counts
Standard Deviation 14.52
|
|
Absolute Change in Mean Lesion Counts at Week 12
Inflammatory lesions
|
-15.6 lesion counts
Standard Deviation 10.41
|
-12.4 lesion counts
Standard Deviation 10.43
|
PRIMARY outcome
Timeframe: Baseline to Week 12Evaluator'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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 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"
|
25.5 percentage of participants
|
13.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12For 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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Percentage Change in Mean Lesion Counts at Week 12
Non-inflammatory lesions
|
-51.36 percentage change
Standard Deviation 36.397
|
41.47 percentage change
Standard Deviation 35.223
|
|
Percentage Change in Mean Lesion Counts at Week 12
Inflammatory lesions
|
-55.52 percentage change
Standard Deviation 36.531
|
-45.70 percentage change
Standard Deviation 36.984
|
SECONDARY outcome
Timeframe: Baseline to Week 12Evaluator'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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 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)
|
28.3 percentage of participants
|
15.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8For 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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Percentage Change in Mean Lesion Counts at Week 8
Non-inflammatory lesions
|
-43.08 percentage change
Standard Deviation 32.430
|
-34.34 percentage change
Standard Deviation 31.684
|
|
Percentage Change in Mean Lesion Counts at Week 8
Inflammatory lesions
|
-45.30 percentage change
Standard Deviation 34.351
|
-38.96 percentage change
Standard Deviation 34.548
|
SECONDARY outcome
Timeframe: Baseline to Week 4For 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.
Outcome measures
| Measure |
IDP-123 Lotion
n=402 Participants
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=411 Participants
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Percentage Change in Mean Lesion Counts at Week 4
Non-inflammatory lesions
|
-29.43 percentage change
Standard Deviation 32.441
|
-23.25 percentage change
Standard Deviation 31.817
|
|
Percentage Change in Mean Lesion Counts at Week 4
Inflammatory lesions
|
-27.27 percentage change
Standard Deviation 34.980
|
-29.70 percentage change
Standard Deviation 34.368
|
Adverse Events
IDP-123 Lotion
Vehicle Lotion
Serious adverse events
| Measure |
IDP-123 Lotion
n=392 participants at risk
IDP-123 (Tazarotene 0.045%) Lotion
|
Vehicle Lotion
n=399 participants at risk
IDP-123 Vehicle Lotion
|
|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
0.26%
1/392 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
0.25%
1/399 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
|
Surgical and medical procedures
Abortion spontaneous
|
0.26%
1/392 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
0.00%
0/399 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.26%
1/392 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
0.00%
0/399 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/392 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
0.25%
1/399 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/392 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
0.25%
1/399 • 12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post-baseline safety assessment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER