Lyra Skin Sciences · DERM-003
Moderate-to-severe atopic dermatitis (combination device)
Combination device + topical study in atopic dermatitis. Enrolment is 4 weeks ahead of plan, all KPIs are within tolerance, and DBL is forecast on time.
Sit-rep
Status
Enrolling
Health
On track
Forecast end
Apr 12, 2027
-3d vs plan
Projected EAC
6.1M USD
-100k USD vs contract
Live activity
No activity yetKey performance indicators
Threshold colour is supplementary to the on-target / at-risk / breached label.
- Enrolment
- 96 / 120 (80%)
- Screen failure rate
- 21%
- Query aging (>14d)
- 8 open
- Protocol deviations
- 6
- Device complaint rate
- 0.9 / 1k days
- Projected DBL variance
- -3 days
- Budget burn
- 62%
- Forecast EAC
- $6.1M
Timeline & milestones
Bar shows planned span; tick marks current forecast end. Markers are colour-coded by milestone status (labels in tooltip / table below).
| Milestone | Planned | Actual / forecast | Variance | Status |
|---|---|---|---|---|
| FPI | Nov 1, 2024 | Oct 28, 2024 | -4d | Complete |
| 25% enrolment | Mar 15, 2025 | Mar 8, 2025 | -7d | Complete |
| 50% enrolment | Jul 30, 2025 | Jul 12, 2025 | -18d | Complete |
| 75% enrolment | Nov 15, 2025 | Oct 22, 2025 | -24d | Complete |
| LPI | Feb 28, 2026 | Feb 15, 2026 | -13d | In progress |
| LPLV | Aug 31, 2026 | Aug 28, 2026 | -3d | Planned |
| Database lock | Nov 15, 2026 | Nov 12, 2026 | -3d | Planned |
| CSR draft | Jan 30, 2027 | Jan 27, 2027 | -3d | Planned |
| CSR final | Apr 15, 2027 | Apr 12, 2027 | -3d | Planned |
| Severity | Title | Owner | Mitigation | Status |
|---|---|---|---|---|
| Medium | Single-source device component supply | Supply Chain Lead | Buffer stock at 3 months; second-source qualification in progress. | Mitigating |
| Low | Subjective endpoint reader drift | Medical Monitor | Calibration sessions every 90 days; QC audit at 50% enrolment passed. | Closed |
| Low | CE-mark renewal aligned with EU MDR transition | Regulatory Lead | Notified body engaged; renewal dossier on track for Q4 2026. | Mitigating |
Resources
| Role | Headcount | FTE | Monthly rate | Monthly cost |
|---|---|---|---|---|
| CRA | 3 | 2.2 | 18k USD | 40k USD |
| Data Management | 2 | 1.6 | 15k USD | 24k USD |
| Pharmacovigilance | 1 | 0.5 | 18k USD | 9k USD |
| Biostatistics | 1 | 0.8 | 22k USD | 17k USD |
| Medical Writing | 1 | 0.3 | 20k USD | 6k USD |
| Total | 8 | 5.4 | — | 97k USD |
Financials
Contracted budget
6.2M USD
EBV spent
3.8M USD
62% of contract
EAC (estimate at completion)
6.1M USD
-100k USD vs contract
Burn vs time elapsed
62% / 66%
broadly aligned
Recent activity
Provenance events (24h)
178
Staging items pending
3
Signatures (7d)
11
View provenance for this study →View staged records for this study →
Study goals
Reach EASI-75 in ≥ 50% of treated subjects at Week 12
Maintain device complaint rate below 2% per 1000 use-days
Hit DBL on the originally planned date
Deliver an investigator-led publication within 6 months of CSR