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-118 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520057-20-00

Acronym

V01-118A-401

Enrollment

Registered

2025-01-28

Start date

2021-03-09

Completion date

2025-11-05

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.) 1 Safety of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily 2.) Systemic exposure of HP, Taz and its metabolite, tazarotenic acid after topical application of IDP-118 Lotion once daily 3.) Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-118 Lotion when applied once daily

Interventions

DRUGDuobrii

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1.) 1 Safety of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily 2.) Systemic exposure of HP, Taz and its metabolite, tazarotenic acid after topical application of IDP-118 Lotion once daily 3.) Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-118 Lotion when applied once daily	—

Countries

Poland

Outcome results

None listed

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