Last updated: July 25, 2023
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Recruiting
Phase
4
Condition
Rosacea
Rash
Warts
Treatment
IDP-122 Lotion
Clinical Study ID
NCT03987763
V01-122A-401
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/or parentor legal guardian.
- Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator'sGlobal Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginousareas are to be excluded in this assessment, if psoriasis is present.
- Has an area of plaque psoriasis appropriate for topical treatment that involves a BSAof 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 treatment containingcorticosteroids within 28 days prior to the screening HPA axis stimulation 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 unsuitable candidatefor the study.
Study Design
Total Participants: 45
Treatment Group(s): 1
Primary Treatment: IDP-122 Lotion
Phase: 4
Study Start date:
October 22, 2019
Estimated Completion Date:
June 30, 2024
Connect with a study center
Bausch Site 4
Panama City,
PanamaSite Not Available
Bausch Site 11
Fountain Valley, California 92708
United StatesActive - Recruiting
Bausch Site 2
Thousand Oaks, California 91320
United StatesActive - Recruiting
Bausch Site 07
Doral, Florida 33166
United StatesActive - Recruiting
Bausch Site 06
Miami, Florida 33155
United StatesActive - Recruiting
Bausch Site 3
Miami, Florida 33125
United StatesActive - Recruiting
Bausch Site 05
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
Bausch Site 1
Spokane, Washington 99216
United StatesTerminated
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