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Tests treatment safety and results for Psoriasis
Official title A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
ClinicalTrials.gov ID: NCT03987763
What this study is testing
What is IDP-122 Lotion?
IDP-122 Lotion is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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...
- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
You likely can't join if
- 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...
- Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment...
- Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Thousand Oaks, California, United States
- Doral, Florida, United States
- Miami, Florida, United States
- Spartanburg, South Carolina, United States
- Spokane, Washington, United States
- Santo Domingo, Dominican Republic
- Panama City, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Thousand Oaks, California, United States; Doral, Florida, United States; Miami, Florida, United States; Spartanburg, South Carolina, United States; Spokane, Washington, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.