New lotion for Kids' psoriasis under the microscope
NCT ID NCT03988439
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a prescription lotion (IDP-118) works in children aged 4 to 16 with moderate to severe plaque psoriasis. Researchers measured how much of the drug enters the bloodstream and whether it affects the body's stress hormone system (HPA axis). The goal was to check safety and absorption, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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16 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bausch Site 1
Henderson, Nevada, 89052, United States
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Bausch Site 11
Miami, Florida, 33173, United States
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Bausch Site 12
Santo Domingo, Dominican Republic
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Bausch Site 2
Panama City, Panama
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Bausch Site 3
Louisville, Kentucky, 40217, United States
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Bausch Site 4
Murray, Utah, 84123, United States
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Bausch Site 5
San Antonio, Texas, 78213, United States
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Bausch Site 6
Saint Joseph, Missouri, 64506, United States
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Bausch Site 7
Doral, Florida, 33166, United States
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