Recent Updates
Recently added Catalysts

IDP-120

Phase 3

Acne Vulgaris | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Mar 29, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment1,557
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03664752Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne VulgarisPHASE3 COMPLETED 585 — — Dec 10, 2018May 7, 2020Mar 29, 202320 United States, Canada
NCT03664739Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne VulgarisPHASE3 COMPLETED 608 — — Dec 5, 2018Mar 23, 2020Mar 29, 202330 United States, Canada
NCT03003247Efficacy and Safety of IDP-120 Gel in the Treatment of Acne VulgarisPHASE2 COMPLETED 364 — — Nov 1, 2015Sep 30, 2016Dec 18, 201724 United States, Canada
Unlock Drug Trial Details
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.

Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
12 Weeks

Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.

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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDP-120 GelEXPERIMENTALIDP-120 Gel, once-daily application
IDP-120 vehicle gelPLACEBO_COMPARATORIDP-120 vehicle gel, once daily application
IDP-120 Component A GelACTIVE_COMPARATORIDP-120 Monad Gel of Component A
IDP-120 Component B GelACTIVE_COMPARATORIDP-120 Monad Gel of Component B
Interventions
NameTypeDescription
IDP-120 GelDRUGIDP-120 Gel, once-daily application
IDP-120 Vehicle GelDRUGIDP-120 Vehicle Gel, once-daily application
IDP 120 Component A GelDRUGMonad of Component A
IDP 120 Component B GelDRUGMonad of Component B
IDP 120 Vehicle GelDRUGVehicle
Unlock Study Design Details
Eligibility Criteria
Age Range9 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites20

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
Unlock Eligibility Criteria