STRATUM Flashcards
STRATUM trial description
Phase 3, parallel-group, DB, vehicle-controlled, 8 week RCT of QD roflumilast FOAM 0.3% for treatment of SD
where was STRATUM conducted?
50 sites across US and CA
who were eligible patients/
- ≥9 years with SD
- ≥3 month duration SD
- IGA score ≥3
- affects ≤20% BSA
- erythema/scaling scores of at least moderate (≥2, 0-4)
randomization for patients
2:1
Primary endpoints
IGA success (0/1+≥2-grade improvement from baseline) at week 8
sample size of X needed for ~90% power to detect a Y% difference
450, 25% difference
Secondary endpoints
- IGA success at weeks 2 and 4
- Erythema score of 0 (0-3)+2-grade improvement from baseline at w8
- scaling score of 0 (0-3)+2-grade improvement at week 8
- % change in daily WI-NRS from baseline (0-10, itch)
- Scalpdex score and dermatology life quality index
how many patients in STRATUM?
N=457, 304 API 153 vehicle
how many patients DCd?
9.4% (43)
primary endpoint results
statistically significantly more rolf-treated patients (79.5%) than vehicle (58%) met primary endpoint at week 8
Statistically significant differences in percentages of patients with IGA Success favored roflumilast at Week 2
roflumilast: 43.0%; vehicle: 25.7%; p<0.001 week 2; roflumilast: 73.1%; vehicle: 47.1%; p<0.001 week 4
More patients treated with roflumilast than vehicle had IGA of 0 (Clear) at Week 8
50.6% vs. 27.7%, respectively; p<0.001
Percentage of patients achieving IGA Success consistent in adolescent patients (age 9-17 years) at Week 8
roflumilast: 76.5%; vehicle: 46.7%
X of patients in either treatment group reported treatment-related TEAEs
3.3%
Among 70 roflumilast-treated patients reporting a TEAE, the worst reported severity was mild or moderate for X and severe for Y; none was considered related to treatment
66 (94.3%), 4 (5.7%, none were treatment-related)
At baseline, Weeks 4 and 8, X of patients had no evidence of irritation on investigator-rated assessments and Y of patients reported a score of 0 (no sensation) or 1 (slight warm, tingling sensation; not really bothersome) on patient-rated tolerability
≥98.9%, ≥92.4%
whichclinically meaningful differences in clinical laboratory assessments or vital signs observed, and assessments of depression, suicidal ideation, and behavior did not indicate any safety concerns
none
Hypo- and hyperpigmentation more common in non-White patients than White patients at baseline
(9.9% vs. 2.5% and 9.9% vs. 1.7%, respectively)
Pigmentary findings improved in both treatment groups during the trial; at Week 8, X and Y of patients with baseline hypo- and hyperpigmentation, respectively experienced full resolution
64.7%; 46.2%
At Week X, new instances of hypopigmentation (n=0) and hyperpigmentation (n=6) were uncommon
8
Conclusions: Once-daily treatment with roflumilast foam, 0.3% resulted in significant and clinically meaningful improvements in key signs and symptoms of seborrheic dermatitis and was well tolerated in patients as young as X years of age
9
Conclusions: Significantly more roflumilast-treated patients than vehicle-treated patients achieved the primary endpoint of IGA Success at Week 8
80% of roflumilast-treated patients achieving IGA Success and >50% achieving clearance
Conclusions: Roflumilast-treated patients had significant reductions in what measurement by 48 hours after first application
WI-NRS
