Clinical trial
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
Name
V01-118A-401
Description
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.
Trial arms
Trial start
2021-03-24
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Phase
Early phase I
Treatment
IDP-118 Lotion
Topical
Arms:
IDP-118 Lotion
Size
45
Primary endpoint
Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2023-07-27
1 organization
1 product
1 indication
Organization
Bausch Health AmericasProduct
IDP-118Indication
Psoriasis