A Phase 2 interventional study of SB204 2% and SB204 4% in Acne Vulgaris, sponsored by Novan, Inc.. Completed at 20 sites in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Novan, Inc. · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Twice daily SB204 2%
Drug: SB204 2%
Once daily SB204 4%
Drug: SB204 4%
Vehicle Gel Daily
Drug: Vehicle Gel
Twice daily Vehicle Gel
Drug: Vehicle Gel
Twice daily SB204 4%
Drug: SB204 4%
Applied topically twice daily
Also known as: NVN1000
Applied topically daily
Also known as: NVN1000
Applied topically twice and once daily
Also known as: Placeco
Absolute Change in Inflammatory Lesion Counts
Change in inflammatory lesion count from Baseline to Week 12
Time frame: Baseline and Week 12
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
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
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
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
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
| Milestone | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Started | 27 | 29 | 53 | 52 | 52 |
| Number of subjects excluded from itt population | 0 | 0 | 0 | 0 | 1 |
| Completed | 24 | 20 | 51 | 48 | 48 |
| Not completed | 3 | 9 | 2 | 4 | 4 |
Change in inflammatory lesion count from Baseline to Week 12
| inflammatory acne lesions | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Absolute Change in Inflammatory Lesion Counts | -7.7 ± 10.51 | -4.1 ± 12.77 | -11.2 ± 9.48 | -11.3 ± 9.66 | -10.4 ± 9.65 |
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
| non-inflammatory acne lesions | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Absolute Change in Non-inflammatory Lesion Counts | -8.4 ± 16.16 | -6.9 ± 18.16 | -12.3 ± 14.91 | -14.1 ± 15.13 | -11.1 ± 17.65 |
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)
| Participants | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | 2 | 2 | 8 | 6 | 7 |
The percent change in inflammatory lesion count from Baseline to Week 12
| Percentage change from baseline | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | -26.2 ± 34.78 | -12.5 ± 48.25 | -41.9 ± 31.35 | -41.6 ± 36.6 | -42.1 ± 35.12 |
The percent change in non-inflammatory lesion count from Baseline to Week 12
| Percentage change from baseline | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | -20.2 ± 42.54 | -14.3 ± 54.10 | -33.8 ± 33.91 | -36.8 ± 35.54 | -33.0 ± 40.16 |
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.
| Weeks | Combined Vehicle | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|
| Median Time to Improvement | 11.6 (1.4 to 12.1) | 2.0 (2.0 to 14) | 4.1 (1.7 to 12.3) | 4.0 (1.6 to 12) |
Collected over Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Gel QD | 0/26 (0%) | 0/26 (0%) | 1/26 (3.8%) |
| Vehicle Gel BID | 0/29 (0%) | 0/29 (0%) | 4/29 (13.8%) |
| SB204 2% BID | 0/53 (0%) | 0/53 (0%) | 4/53 (7.5%) |
| SB204 4% QD | 0/52 (0%) | 1/52 (1.9%) | 5/52 (9.6%) |
| SB204 4% BID | 0/51 (0%) | 0/51 (0%) | 3/51 (5.9%) |
| Event | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| Peritoneal haemorrhageGastrointestinal disorders | 0/26 | 0/29 | 0/53 | 1/52 | 0/51 |
| Event | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/26 | 2/29 | 3/53 | 2/52 | 1/51 |
| HeadacheNervous system disorders | 0/26 | 2/29 | 1/53 | 0/52 | 1/51 |
| Application site drynessGeneral disorders | 0/26 | 0/29 | 0/53 | 3/52 | 1/51 |
Intent to Treat (ITT) population: all study subjects who were randomized and dispensed study medication. One subject in the SB204 4% BID group was randomized but did not receive study medication.
| Age, Continuous(years) | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total |
|---|---|---|---|---|---|---|
| SB204 | — | — | 20.1 ± 6.81 | 18.8 ± 5.00 | 20.1 ± 6.94 | 19.6 ± 6.30 |
| Vehicle | 16.7 ± 4.84 | 19.7 ± 6.33 | — | — | — | 18.2 ± 5.81 |
| Sex: Female, Male(Participants) | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total |
|---|---|---|---|---|---|---|
| SB204 — Female | — | — | 26 | 29 | 29 | 84 |
| SB204 — Male | — | — | 27 | 23 | 22 | 72 |
| Vehicle — Female | 11 | 16 | — | — | — | 27 |
| Vehicle — Male | 16 | 13 | — | — | — | 29 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total |
|---|---|---|---|---|---|---|
| SB204 — Hispanic or Latino | — | — | 13 | 10 | 9 | 32 |
| SB204 — Not Hispanic or Latino | — | — | 40 | 42 | 42 | 124 |
| SB204 — Unknown or Not Reported | — | — | 0 | 0 | 0 | 0 |
| Vehicle — Hispanic or Latino | 4 | 4 | — | — | — | 8 |
| Vehicle — Not Hispanic or Latino | 23 | 25 | — | — | — | 48 |
| Vehicle — Unknown or Not Reported | 0 | 0 | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total |
|---|---|---|---|---|---|---|
| SB204 — American Indian or Alaska Native | — | — | 0 | 0 | 0 | 0 |
| SB204 — Asian | — | — | 2 | 3 | 3 | 8 |
| SB204 — Native Hawaiian or Other Pacific Islander | — | — | 1 | 2 | 0 | 3 |
| SB204 — Black or African American | — | — | 9 | 6 | 10 | 25 |
| SB204 — White | — | — | 41 | 36 | 36 | 113 |
| SB204 — More than one race | — | — | 0 | 5 | 2 | 7 |
| SB204 — Unknown or Not Reported | — | — | 0 | 0 | 0 | 0 |
| Vehicle — American Indian or Alaska Native | 0 | 0 | — | — | — | 0 |
| Vehicle — Asian | 0 | 0 | — | — | — | 0 |
| Vehicle — Native Hawaiian or Other Pacific Islander | 0 | 0 | — | — | — | 0 |
| Vehicle — Black or African American | 4 | 5 | — | — | — | 9 |
| Vehicle — White | 23 | 21 | — | — | — | 44 |
| Vehicle — More than one race | 0 | 3 | — | — | — | 3 |
| Vehicle — Unknown or Not Reported | 0 | 0 | — | — | — | 0 |
| Region of Enrollment(Participants) | Vehicle Gel QD | Vehicle Gel BID | SB204 2% BID | SB204 4% QD | SB204 4% BID | Total |
|---|---|---|---|---|---|---|
| United States — SB204 | 0 | 0 | 53 | 52 | 51 | 156 |
| United States — Vehicle | 27 | 29 | 0 | 0 | 0 | 56 |
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Novan, Inc.