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IDP-123

Phase 3

Acne Vulgaris | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Apr 1, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment1,824
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03168334A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)PHASE3 COMPLETED 801Jul 11, 2017Jul 24, 2018Apr 1, 202145 United States, Canada
NCT03168321A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)PHASE3 COMPLETED 813Jun 29, 2017Jun 7, 2018Apr 1, 202145 United States, Canada
NCT02938494Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne VulgarisPHASE2 COMPLETED 210Nov 1, 2015Sep 1, 2016Sep 23, 202016 United States
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Study Endpoints
Primary Endpoints
Absolute Change in Mean Lesion Counts at Week 12
Baseline to Week 12

For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
Baseline to Week 12

Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Baseline (Day 0), Week 12

Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.

Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Baseline, Week 12

Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

Percentage of Participants With Treatment Success at Week 12
Baseline, Week 12

Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Secondary Endpoints
Percentage Change in Mean Lesion Counts at Week 12
Baseline to Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Baseline to Week 12
Percentage Change in Mean Lesion Counts at Week 8
Baseline to Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDP-123 LotionEXPERIMENTALTazarotene 0.045% Lotion
IDP-123 Vehicle LotionPLACEBO_COMPARATORVehicle Lotion
Tazorac CreamACTIVE_COMPARATORCream
Vehicle LotionACTIVE_COMPARATORLotion
Vehicle CreamACTIVE_COMPARATORCream
Interventions
NameTypeDescription
IDP-123 LotionDRUGTazarotene 0.045% Lotion
IDP-123 Vehicle LotionDRUGVehicle Lotion
Tazorac CreamDRUGCream
Vehicle LotionDRUGLotion
Vehicle CreamDRUGCream
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Eligibility Criteria
Age Range9 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: 1. Male or female at least 9 years of age and older; 2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent du...

Countries:United StatesCanada
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