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A Phase 4 (Phase 2 in European Union), Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520058-39-00
Acronym
V01-122A-401
Enrollment
26
Registered
2025-01-28
Start date
2020-12-28
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief summary

1 Safety of IDP-122 (HP 0.01%) Lotion administered topically once daily 2 Systemic exposure of HP after topical application of IDP-122 Lotion once daily 3 Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-122 Lotion when applied once daily

Interventions

Sponsors

Bausch Health Americas Inc., Bausch Health Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1 Safety of IDP-122 (HP 0.01%) Lotion administered topically once daily 2 Systemic exposure of HP after topical application of IDP-122 Lotion once daily 3 Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-122 Lotion when applied once daily

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026