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ACYC

Phase 3

Acne | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Jun 4, 2018

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_CONTROLLED
Total Trials1
Total Enrollment498
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01701024Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe AcnePHASE3 COMPLETED 498Oct 1, 2012Jul 1, 2013Jun 4, 201824 United States
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Study Endpoints
Primary Endpoints
Absolute Change in Inflammatory Lesion Count
Baseline and 12 Weeks
Absolute Change in Non-inflammatory Lesion Count
Baseline and 12 Weeks
Percent of Subjects Who Have a Least a 2 Grade Reduction
Baseline and 12 Weeks
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
Baseline and 12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACYCACTIVE_COMPARATORACYC active, topically applied to the face for 12 weeks
ACYC vehiclePLACEBO_COMPARATORACYC vehicle (placebo), topically applied to the face for 12 weeks
Interventions
NameTypeDescription
ACYCDRUGACYC active, topically applied to the face for 12 weeks
ACYC vehicleDRUGACYC vehicle (placebo), topically applied to the face for 12 weeks
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Eligibility Criteria
Age Range12 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites24

Key Inclusion Criteria: * Male or female between the ages of 12 and 40 (inclusive) * Written and verbal informed consent must be obtained. * Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent * Subject must have moder...

Countries:United States
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