A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 4, 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988439
• Other study ID #: V01-118A-401
• Status: Recruiting
• Phase: Phase 4
• Start date: March 24, 2021
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Bausch Health Americas, Inc.
• Contact: Alison Magnotti-Nagel
• Phone: 19085418664
• Email: alison.magnotti-nagel[@]bauschhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Is 4 to 16 years 11 months of age at time of informed consent/assent obtained.

• Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.

• Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.

• Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.

• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

• Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is >18 µg/dL at the Screening visit.

• Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

• Has a history of adrenal disease.

• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.

• Is pregnant, nursing an infant, or planning a pregnancy during the study period.

• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device.

• Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.

• Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.

• Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IDP-118 Lotion
Topical

Locations

Country	Name	City	State
Panama	Bausch Site 2	Panama City
United States	Bausch Site 7	Doral	Florida
United States	Bausch Site 1	Henderson	Nevada
United States	Bausch Site 3	Louisville	Kentucky
United States	Bausch Site 11	Mayfield Heights	Ohio
United States	Bausch Site 8	Miami	Florida
United States	Bausch Site 4	Murray	Utah
United States	Bausch Site 6	Saint Joseph	Missouri
United States	Bausch Site 5	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes	On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes.	0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
Secondary	Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8	An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of =18 micrograms/deciliter (µg/dL) at the end of the study.	Week 8