Phase
Condition
Warts
Rash
Scalp Disorders
Treatment
IDP-122 Lotion
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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/orparent or legal guardian.
Has a clinical diagnosis of psoriasis at Screening and Baseline with anInvestigator'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 ispresent.
Has an area of plaque psoriasis appropriate for topical treatment that involves aBSA of at least 10% at Screening and Baseline. The face, scalp, axillae, andintertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultravioletradiation (natural and artificial) for the duration of the study.
Is in good general adrenal health, as determined by a 30-minute postcosyntropinstimulation 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
Exclusion Criteria:
Has a history of adrenal disease.
Presents with any concurrent skin condition that could interfere with the evaluationof 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 5drug half-lives (whichever is longer) prior to baseline or is concurrentlyparticipating in another clinical study with an investigational drug or device.
Received treatment with a topical antipsoriatic drug product other thancorticosteroids within 14 days prior to the Baseline visit and/or treatmentcontaining corticosteroids within 28 days prior to the screening HPA axisstimulation test.
Has a history of hypersensitivity or allergic reaction to any of the study drugconstituents.
Is considered by the Investigator, for any other reason, to be an unsuitablecandidate for the study.
Study Design
Connect with a study center
Bausch Site 12
Santo Domingo 3492908,
Dominican RepublicActive - Recruiting
Bausch Site 4
Panama City,
PanamaSite Not Available
Bausch Site 4
Panama City 3703443,
PanamaTerminated
Bausch Site 11
Fountain Valley, California 92708
United StatesSite Not Available
Bausch Site 2
Thousand Oaks, California 91320
United StatesSite Not Available
Bausch Site 11
Fountain Valley 5350207, California 5332921 92708
United StatesTerminated
Bausch Site 2
Thousand Oaks 5402405, California 5332921 91320
United StatesActive - Recruiting
Bausch Site 07
Doral, Florida 33166
United StatesSite Not Available
Bausch Site 06
Miami, Florida 33155
United StatesSite Not Available
Bausch Site 3
Miami, Florida 33125
United StatesActive - Recruiting
Bausch Site 07
Doral 4153471, Florida 4155751 33166
United StatesActive - Recruiting
Bausch Site 06
Miami 4164138, Florida 4155751 33155
United StatesTerminated
Bausch Site 3
Miami 4164138, Florida 4155751 33125
United StatesActive - Recruiting
Bausch Site 05
Spartanburg, South Carolina 29303
United StatesSite Not Available
Bausch Site 05
Spartanburg 4597200, South Carolina 4597040 29303
United StatesTerminated
Bausch Site 1
Spokane, Washington 99216
United StatesSite Not Available
Bausch Site 1
Spokane 5811696, Washington 5815135 99216
United StatesTerminated

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