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IDP-121

Phase 3

Acne | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Jan 3, 2020

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment1,660
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02965456Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne VulgarisPHASE3 COMPLETED 820Nov 4, 2015Feb 23, 2017Dec 18, 201934 United States
NCT02932306Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne VulgarisPHASE3 COMPLETED 820Nov 3, 2015Feb 22, 2017Jan 3, 202039 United States
NCT02849860Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne VulgarisPHASE1 COMPLETED 20Feb 1, 2014Oct 1, 2016Dec 14, 20172 United States
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Study Endpoints
Primary Endpoints
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.

Evaluators Global Severity Score at Day 15
15 Days

Acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).

Secondary Endpoints
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDP-121 LotionEXPERIMENTALIDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
IDP-121 Vehicle LotionPLACEBO_COMPARATORIDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
Interventions
NameTypeDescription
IDP 121 LotionDRUGIDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
IDP-121 Vehicle LotionDRUGIDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
IDP-121 LotionDRUGIDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
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Eligibility Criteria
Age Range9 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites34

Key Inclusion Criteria: * Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Participants 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 participant reaches age of ...

Countries:United States
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