Table 2. Summary of Treatment-Emergent Adverse Events, Local Skin Reactions, and Scarring for the Safety Set.
| Event or reaction | Patients, No. (%) | |
|---|---|---|
| Berdazimer gel, 10.3% (n = 444) | Vehicle (n = 447) | |
| Patients with ≥1 TEAEa | 191 (43.0) | 103 (23.0) |
| Mild | 108 (24.3) | 75 (16.8) |
| Moderate | 78 (17.6) | 26 (5.8) |
| Severe | 5 (1.1) | 2 (0.4) |
| TEAEs at application site affecting ≥5% of patients in group, by severity | ||
| Pain | ||
| Mild | 64 (14.4) | 21 (4.7) |
| Moderate | 18 (4.1) | 2 (0.4) |
| Severe | 1 (0.2) | 0 |
| Erythema | ||
| Mild | 25 (5.6) | 5 (1.1) |
| Moderate | 26 (5.9) | 1 (0.2) |
| Severe | 1 (0.2) | 0 |
| Pruritus | ||
| Mild | 25 (5.6) | 4 (0.9) |
| Moderate | 8 (1.8) | 1 (0.2) |
| Severe | 0 | 0 |
| Exfoliation | ||
| Mild | 11 (2.5) | 0 |
| Moderate | 16 (3.6) | 0 |
| Severe | 0 | 0 |
| Dermatitis | ||
| Mild | 8 (1.8) | 1 (0.2) |
| Moderate | 16 (3.6) | 2 (0.4) |
| Severe | 2 (0.5) | 0 |
| Scarb | ||
| Mild | 20 (4.5) | 28 (6.3) |
| Moderate | 1 (0.2) | 0 |
| Severe | 0 | 0 |
| Patients with ≥1 serious TEAE | 0 | 1 (0.2)c |
| Patients with ≥1 TEAE and discontinuation | 18 (4.1) | 3 (0.7) |
| Application site | ||
| Pain | 10 (2.3) | 3 (0.7) |
| Dermatitis | 4 (0.9) | 0 |
| Eczema | 1 (0.2) | 0 |
| Erythema | 1 (0.2) | 1 (0.2) |
| Pruritus | 1 (0.2) | 0 |
| Vesicles | 1 (0.2) | 0 |
| Molluscum contagiosum | 1 (0.2) | 0 |
| Dermatitis contact | 1 (0.2) | 0 |
| LSRs at weeks 2, 4, 8, and 12 | ||
| Mean LSR composite score (0-24)d | ||
| 2 | 2.3 | 0.6 |
| 4 | 2.4 | 0.5 |
| 8 | 1.8 | 0.6 |
| 12 | 1.0 | 0.5 |
| Individual LSR component score e , f | ||
| Erythema, No.g | ||
| 2 | 206 (50) | 100 (24) |
| 4 | 195 (47) | 89 (21) |
| 8 | 166 (42) | 81 (20) |
| 12 | 110 (28) | 82 (21) |
| Severity at week 12, %h | ||
| 0 | 71.8 | 79.3 |
| 1 | 16.9 | 14.1 |
| 2 | 7.9 | 5.5 |
| 3 | 2.6 | 0.5 |
| 4 | 0.8 | 0.5 |
| Flaking/scaling, No.g | ||
| 2 | 141 (34) | 48 (12) |
| 4 | 142 (35) | 37 (9) |
| 8 | 125 (32) | 37 (9) |
| 12 | 79 (20) | 37 (9) |
| Severity at week 12, %h | ||
| 0 | 79.7 | 90.7 |
| 1 | 15.6 | 8.3 |
| 2 | 3.3 | 1.0 |
| 3 | 1.0 | 0 |
| 4 | 0.3 | 0 |
| Crusting, No.g | ||
| 2 | 92 (22) | 25 (6) |
| 4 | 89 (22) | 19 (5) |
| 8 | 82 (21) | 23 (6) |
| 12 | 36 (9) | 20 (5) |
| Severity at week 12, %h | ||
| 0 | 90.8 | 95.0 |
| 1 | 6.9 | 4.3 |
| 2 | 1.3 | 0.8 |
| 3 | 1.0 | 0 |
| 4 | 0 | 0 |
| Swelling, No.g | ||
| 2 | 90 (22) | 17 (4) |
| 4 | 84 (20) | 16 (4) |
| 8 | 64 (16) | 25 (6) |
| 12 | 30 (8) | 17 (4) |
| Severity at week 12, %h | ||
| 0 | 92.3 | 95.7 |
| 1 | 4.6 | 2.8 |
| 2 | 1.8 | 1.0 |
| 3 | 1.3 | 0.5 |
| 4 | 0 | 0 |
| Scarsi | ||
| Week 12 | 13 (2.9) | 10 (2.2) |
| Week 24 | 12 (2.7) | 18 (4.0) |
| Hypo- and hyperpigmentation | ||
| Through week 12 | 6 (1.4) | 0 |
| Through week 24 | 3 (0.7) | 0 |
Abbreviations: AE, adverse event; LSR, local skin reaction; TEAE, treatment-emergent adverse event.
Events that occurred or worsened on or after first application through last application of medication.
The US Food and Drug Administration required that temporary epidermal atrophy from the resolution of a space occupying lesion be captured as a scar.
Humerus fracture deemed not treatment related.
Sum of 6 LSR component scores (range, 0-4 for each component).
Most patients (≥92%) in both groups had an absence of vesiculation/pustulation and erosion/ulceration at week 12; therefore, these data are not shown.
In the berdazimer group, 7 patients had local skin reactions suggestive of allergic contact dermatitis; however, only 1 patient underwent patch testing that confirmed a sensitization reaction.
Percentages for LSRs over time are based on observed data at each time point and represent the sum of all patients with a score of 1, 2, 3, or 4.
Based on a 5-point scale, from 0 (not present) to 4 (severe) described in the eTable in Supplement 2.
Scar assessment was performed at each visit independent of AE assessment. Clinically important scars were reported as AEs. No patients in either group had keloidal or hypertrophic scars during the 24-week study period.