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Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of ACYC and ACYC Vehicle Gel in the Treatment of Acne Vulgaris

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01701024
Acronym
ACYC
Enrollment
498
Registered
2012-10-04
Start date
2012-10-31
Completion date
2013-07-31
Last updated
2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Keywords

Acne

Brief summary

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

Detailed description

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Interventions

DRUGACYC

ACYC active, topically applied to the face for 12 weeks

DRUGACYC vehicle

ACYC vehicle (placebo), topically applied to the face for 12 weeks

Sponsors

Dow Pharmaceutical Sciences
CollaboratorINDUSTRY
Bausch Health Americas, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

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 moderate to severe acne at the baseline visit * Women of childbearing potential must be willing to practice effective contraception for the duration of the study Key

Exclusion criteria

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study * Dermatological conditions on the face that could interfere with clinical evaluations

Design outcomes

Primary

MeasureTime frame
Absolute Change in Inflammatory Lesion CountBaseline and 12 Weeks
Absolute Change in Non-inflammatory Lesion CountBaseline and 12 Weeks
Percent of Subjects Who Have a Least a 2 Grade ReductionBaseline and 12 Weeks
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost ClearBaseline and 12 Weeks

Countries

United States

Participant flow

Participants by arm

ArmCount
ACYC
ACYC active, topically applied to the face for 12 weeks
253
ACYC Vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
245
Total498

Baseline characteristics

CharacteristicTotalACYCACYC Vehicle
Age, Continuous18.7 years
STANDARD_DEVIATION 5.82
18.2 years
STANDARD_DEVIATION 5.6
19.3 years
STANDARD_DEVIATION 6
Ethnicity (NIH/OMB)
Hispanic or Latino
136 Participants64 Participants72 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
362 Participants189 Participants173 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Evaluator's Global Severity Score (EGSS)
Almost Clear
0 participants0 participants0 participants
Evaluator's Global Severity Score (EGSS)
Clear
0 participants0 participants0 participants
Evaluator's Global Severity Score (EGSS)
Mild
0 participants0 participants0 participants
Evaluator's Global Severity Score (EGSS)
Moderate
412 participants212 participants200 participants
Evaluator's Global Severity Score (EGSS)
Severe
86 participants41 participants45 participants
Evaluator's Global Severity Score (EGSS)
Very Severe
0 participants0 participants0 participants
Inflammatory Lesion Count27 Lesions
STANDARD_DEVIATION 6.04
27.2 Lesions
STANDARD_DEVIATION 5.99
26.7 Lesions
STANDARD_DEVIATION 6.09
Non-Inflammatory Lesion Count37.8 Lesions
STANDARD_DEVIATION 17.87
38.3 Lesions
STANDARD_DEVIATION 18.63
37.2 Lesions
STANDARD_DEVIATION 17.07
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
10 Participants6 Participants4 Participants
Race (NIH/OMB)
Black or African American
57 Participants33 Participants24 Participants
Race (NIH/OMB)
More than one race
11 Participants5 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
418 Participants208 Participants210 Participants
Sex: Female, Male
Female
242 Participants123 Participants119 Participants
Sex: Female, Male
Male
256 Participants130 Participants126 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
38 / 24331 / 236
serious
Total, serious adverse events
0 / 2430 / 236

Outcome results

Primary

Absolute Change in Inflammatory Lesion Count

Time frame: Baseline and 12 Weeks

ArmMeasureValue (MEAN)Dispersion
ACYCAbsolute Change in Inflammatory Lesion Count16.3 Lesion countStandard Deviation 9.75
ACYC VehicleAbsolute Change in Inflammatory Lesion Count8.2 Lesion countStandard Deviation 11.55
Primary

Absolute Change in Non-inflammatory Lesion Count

Time frame: Baseline and 12 Weeks

ArmMeasureValue (MEAN)Dispersion
ACYCAbsolute Change in Non-inflammatory Lesion Count19.2 lesion countStandard Deviation 16.18
ACYC VehicleAbsolute Change in Non-inflammatory Lesion Count9.6 lesion countStandard Deviation 17.49
Primary

Percent of Subjects Who Have a Least a 2 Grade Reduction

Time frame: Baseline and 12 Weeks

ArmMeasureValue (NUMBER)
ACYCPercent of Subjects Who Have a Least a 2 Grade Reduction35.2 Percent with >2% reduction
ACYC VehiclePercent of Subjects Who Have a Least a 2 Grade Reduction17 Percent with >2% reduction
Primary

Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear

Time frame: Baseline and 12 Weeks

ArmMeasureValue (NUMBER)
ACYCPercent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear28.5 percentage of clear or almost clear
ACYC VehiclePercent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear14.5 percentage of clear or almost clear

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026