Recent Updates
Recently added Catalysts

ACYC

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment498

FDA Designations

No designations recorded

Clinical trial landscape

ACYC · 1 trial · 1 indication

Phase 3 1
NCT01701024Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe AcneAcne
COMPLETED498 Analytics
PHASE3COMPLETED
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Acne
NCT01701024498
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range12 Years to 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
Unlock Eligibility Criteria

Competitive Landscape -Acne 10 trials

CompanyTickerTrialsLead PhaseDrugs
Sunshine Biopharma IncorporatedSBFM2PHASE31% Clascoterone
Sanofi SA Sponsored ADRSNY3PHASE1Acne mRNA vaccine
Hoth Therapeutics, Inc.HOTH1PHASE2HT-001 2%, HT-001 1%, HT-001 0.5%
Sagimet Biosciences Inc. Class ASGMT1PHASE1TVB-3567
Bausch Health Companies Inc.BHC1 - clindamycin, adapalene and benzoyl peroxide
Unlock Competitive Intelligence

Frequently asked questions about ACYC

What is ACYC used for?

ACYC is an investigational small molecule being developed for the treatment of moderate to severe acne. It is intended for use in patients aged 12 years and older. The drug is currently in Phase 3 clinical development, though the specific trial for this indication has been completed.

Who makes ACYC?

ACYC is being developed by Bausch Health Companies Inc., a company publicly traded under the ticker symbol BHC. The company is conducting clinical research to evaluate the safety and efficacy of ACYC for the treatment of acne.

What phase is ACYC in?

ACYC is in Phase 3 clinical development for the treatment of acne. A Phase 3 clinical trial has been completed, but the drug is not yet approved and remains investigational. Further regulatory review and potential additional studies may be required before it can be considered for approval.

What clinical trials is ACYC in?

ACYC has one completed Phase 3 clinical trial, identified by the identifier NCT01701024. This study was a randomized, double-blind, placebo-controlled trial that enrolled 498 participants with moderate to severe acne in the United States. The trial included patients aged 12 years and older.

Is ACYC FDA approved?

ACYC is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial for acne, but it has not yet received regulatory approval. The drug remains in clinical development, and its safety and efficacy have not been fully established for commercial use.