NCT03987763 A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
| NCT ID | NCT03987763 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bausch Health Americas, Inc. |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2019-10-22 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 45 participants in total. It began in 2019-10-22 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.
Eligibility Criteria
Inclusion Criteria: * Is 6 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.
Contact & Investigator
Alison Magnotti-Nagel
STUDY DIRECTOR
Bausch Health Americas, Inc.
Frequently Asked Questions
Who can join the NCT03987763 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03987763 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03987763 currently recruiting?
Yes, NCT03987763 is actively recruiting participants. Contact the research team at alison.magnotti-nagel@bauschhealth.com for enrollment information.
Where is the NCT03987763 trial being conducted?
This trial is being conducted at Fountain Valley, United States, Thousand Oaks, United States, Doral, United States, Miami, United States and 5 additional locations.
Who is sponsoring the NCT03987763 clinical trial?
NCT03987763 is sponsored by Bausch Health Americas, Inc.. The principal investigator is Alison Magnotti-Nagel at Bausch Health Americas, Inc.. The trial plans to enroll 45 participants.
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