Acne Vulgaris
Conditions
Keywords
acne
Brief summary
This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
Detailed description
A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
Interventions
DRUGSB204 2%
Applied topically twice daily
DRUGSB204 4%
Applied topically daily
DRUGVehicle Gel
Applied topically twice and once daily
Sponsors
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe acne * 25-70 non-inflammatory lesions at Baseline * 20-40 inflammatory lesions at Baseline
Exclusion criteria
* Subjects with known allergy to any component of the test material or vehicle * Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Inflammatory Lesion Counts | Baseline and Week 12 | Change in inflammatory lesion count from Baseline to Week 12 |
| Absolute Change in Non-inflammatory Lesion Counts | Baseline and Week 12 | Absolute Change in non-inflammatory lesion count from Baseline to Week 12 |
| Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | Baseline and Week 12 | Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline and Week 12 | The percent change in inflammatory lesion count from Baseline to Week 12 |
| Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | Baseline and Week 12 | The percent change in non-inflammatory lesion count from Baseline to Week 12 |
| Median Time to Improvement | Baseline through Week 12 | Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Gel QD Vehicle Gel: Applied topically once daily | 27 |
| Vehicle Gel BID Vehicle Gel: Applied topically twice daily | 29 |
| SB204 2% BID SB204 2%: Applied topically twice daily | 53 |
| SB204 4% QD SB204 4%: Applied topically once daily | 52 |
| SB204 4% BID SB204 4%: Applied topically twice daily | 51 |
| Total | 212 |
Baseline characteristics
| Characteristic | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total | Vehicle Gel QD | Vehicle Gel BID |
|---|---|---|---|---|---|---|
| Age, Continuous SB204 | 20.1 years STANDARD_DEVIATION 6.81 | 18.8 years STANDARD_DEVIATION 5 | 20.1 years STANDARD_DEVIATION 6.94 | 19.6 years STANDARD_DEVIATION 6.3 | — | — |
| Age, Continuous Vehicle | — | — | — | 18.2 years STANDARD_DEVIATION 5.81 | 16.7 years STANDARD_DEVIATION 4.84 | 19.7 years STANDARD_DEVIATION 6.33 |
| Ethnicity (NIH/OMB) SB204 Hispanic or Latino | 13 Participants | 10 Participants | 9 Participants | 32 Participants | — | — |
| Ethnicity (NIH/OMB) SB204 Not Hispanic or Latino | 40 Participants | 42 Participants | 42 Participants | 124 Participants | — | — |
| Ethnicity (NIH/OMB) SB204 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Ethnicity (NIH/OMB) Vehicle Hispanic or Latino | — | — | — | 8 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Vehicle Not Hispanic or Latino | — | — | — | 48 Participants | 23 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Vehicle Unknown or Not Reported | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) SB204 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) SB204 Asian | 2 Participants | 3 Participants | 3 Participants | 8 Participants | — | — |
| Race (NIH/OMB) SB204 Black or African American | 9 Participants | 6 Participants | 10 Participants | 25 Participants | — | — |
| Race (NIH/OMB) SB204 More than one race | 0 Participants | 5 Participants | 2 Participants | 7 Participants | — | — |
| Race (NIH/OMB) SB204 Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 3 Participants | — | — |
| Race (NIH/OMB) SB204 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) SB204 White | 41 Participants | 36 Participants | 36 Participants | 113 Participants | — | — |
| Race (NIH/OMB) Vehicle American Indian or Alaska Native | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Vehicle Asian | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Vehicle Black or African American | — | — | — | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Vehicle More than one race | — | — | — | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Vehicle Native Hawaiian or Other Pacific Islander | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Vehicle Unknown or Not Reported | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Vehicle White | — | — | — | 44 Participants | 23 Participants | 21 Participants |
| Region of Enrollment United States SB204 | 53 Participants | 52 Participants | 51 Participants | 156 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Vehicle | 0 Participants | 0 Participants | 0 Participants | 56 Participants | 27 Participants | 29 Participants |
| Sex: Female, Male SB204 Female | 26 Participants | 29 Participants | 29 Participants | 84 Participants | — | — |
| Sex: Female, Male SB204 Male | 27 Participants | 23 Participants | 22 Participants | 72 Participants | — | — |
| Sex: Female, Male Vehicle Female | — | — | — | 27 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Vehicle Male | — | — | — | 29 Participants | 16 Participants | 13 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 / 26 | 0 / 29 | 0 / 53 | 0 / 52 | 0 / 51 |
| other Total, other adverse events | 1 / 26 | 4 / 29 | 4 / 53 | 5 / 52 | 3 / 51 |
| serious Total, serious adverse events | 0 / 26 | 0 / 29 | 0 / 53 | 1 / 52 | 0 / 51 |
Outcome results
Primary
Absolute Change in Inflammatory Lesion Counts
Change in inflammatory lesion count from Baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent to treat population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel QD | Absolute Change in Inflammatory Lesion Counts | -7.7 inflammatory acne lesions | Standard Deviation 10.51 |
| Vehicle Gel BID | Absolute Change in Inflammatory Lesion Counts | -4.1 inflammatory acne lesions | Standard Deviation 12.77 |
| SB204 2% BID | Absolute Change in Inflammatory Lesion Counts | -11.2 inflammatory acne lesions | Standard Deviation 9.48 |
| SB204 4% QD | Absolute Change in Inflammatory Lesion Counts | -11.3 inflammatory acne lesions | Standard Deviation 9.66 |
| SB204 4% BID | Absolute Change in Inflammatory Lesion Counts | -10.4 inflammatory acne lesions | Standard Deviation 9.65 |
Primary
Absolute Change in Non-inflammatory Lesion Counts
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent to treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel QD | Absolute Change in Non-inflammatory Lesion Counts | -8.4 non-inflammatory acne lesions | Standard Deviation 16.16 |
| Vehicle Gel BID | Absolute Change in Non-inflammatory Lesion Counts | -6.9 non-inflammatory acne lesions | Standard Deviation 18.16 |
| SB204 2% BID | Absolute Change in Non-inflammatory Lesion Counts | -12.3 non-inflammatory acne lesions | Standard Deviation 14.91 |
| SB204 4% QD | Absolute Change in Non-inflammatory Lesion Counts | -14.1 non-inflammatory acne lesions | Standard Deviation 15.13 |
| SB204 4% BID | Absolute Change in Non-inflammatory Lesion Counts | -11.1 non-inflammatory acne lesions | Standard Deviation 17.65 |
Primary
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
Time frame: Baseline and Week 12
Population: Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Gel QD | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 2 Participants |
| Vehicle Gel BID | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 2 Participants |
| SB204 2% BID | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 8 Participants |
| SB204 4% QD | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 6 Participants |
| SB204 4% BID | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 7 Participants |
Secondary
Median Time to Improvement
Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.
Time frame: Baseline through Week 12
Population: Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Gel QD | Median Time to Improvement | 11.6 Weeks |
| Vehicle Gel BID | Median Time to Improvement | 2.0 Weeks |
| SB204 2% BID | Median Time to Improvement | 4.1 Weeks |
| SB204 4% QD | Median Time to Improvement | 4.0 Weeks |
Secondary
Percent Change in Inflammatory Lesion Count From Baseline to Week 12
The percent change in inflammatory lesion count from Baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent to treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel QD | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -26.2 Percentage change from baseline | Standard Deviation 34.78 |
| Vehicle Gel BID | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -12.5 Percentage change from baseline | Standard Deviation 48.25 |
| SB204 2% BID | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -41.9 Percentage change from baseline | Standard Deviation 31.35 |
| SB204 4% QD | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -41.6 Percentage change from baseline | Standard Deviation 36.6 |
| SB204 4% BID | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -42.1 Percentage change from baseline | Standard Deviation 35.12 |
Secondary
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
The percent change in non-inflammatory lesion count from Baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent to treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel QD | Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -20.2 Percentage change from baseline | Standard Deviation 42.54 |
| Vehicle Gel BID | Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -14.3 Percentage change from baseline | Standard Deviation 54.1 |
| SB204 2% BID | Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -33.8 Percentage change from baseline | Standard Deviation 33.91 |
| SB204 4% QD | Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -36.8 Percentage change from baseline | Standard Deviation 35.54 |
| SB204 4% BID | Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -33.0 Percentage change from baseline | Standard Deviation 40.16 |