AcnePhase 3ACYCNCT01701024

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

A Phase 3 study testing ACYC in people with Acne, run by Bausch Health Americas, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 to 40 years
Conditions the study is for: Acne
What is being tested?: ACYC
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 498 participants
Where: 24 sitesUnited States
Study dates: Oct 2012to Jul 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Study site
Albuquerque, New Mexico, 87106
Study site
Austin, Texas, 78759
Study site
Aventura, Florida, 33180
Study site
Clinton Township, Michigan, 48038
Study site
College Station, Texas, 77845
Study site
Evansville, Indiana, 47714
Study site
Fridley, Minnesota, 55432
Study site
Goodlettsville, Tennessee, 37072
Study site
Houston, Texas, 77056
Study site
Los Angeles, California, 90045
Study site
Louisville, Kentucky, 40202
Study site
Lynchburg, Virginia, 24501
Study site
Mobile, Alabama, 36608
Study site
Naperville, Illinois, 60563
Study site
New Haven, Connecticut, 06511
Study site
Norfolk, Virginia, 23507
Study site
Omaha, Nebraska, 68144
Study site
Portland, Oregon, 97210
Study site
Raleigh, North Carolina, 27612
Study site
Rochester, New York, 14623
Study site
Salt Lake City, Utah, 84117
Study site
San Antonio, Texas, 78250
Study site
San Diego, California, 92123
Study site
South Bend, Indiana, 46617

Other trials in United States

About this study

Official title: 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

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.

Read the 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

Conditions: Acne
Being tested: ACYC, ACYC vehicle
Keywords: Acne
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01701024
Study group	Role	What they receive
ACYC	Active comparator	ACYC active, topically applied to the face for 12 weeks Receives: Drug: ACYC
ACYC vehicle	Placebo comparator	ACYC vehicle (placebo), topically applied to the face for 12 weeks Receives: Drug: ACYC vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change in Inflammatory Lesion Count
Measured: Baseline and 12 Weeks
Absolute Change in Non-inflammatory Lesion Count
Measured: Baseline and 12 Weeks
Percent of Subjects Who Have a Least a 2 Grade Reduction
Measured: Baseline and 12 Weeks
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
Measured: Baseline and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jul 2013

First posted4 Oct 2012 (estimated)
Study startOct 2012
Primary completionMay 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AcneStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 498 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01701024
Sponsor's protocol ID: V01-ACYC-301
Acronym: ACYC
Status last verified: May 2018
First submitted: 27 Sep 2012
Last updated: 4 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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All Acne trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01701024
Acronym / sponsor ID: ACYC / V01-ACYC-301
Conditions: Acne
Keywords: Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 498 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Collaborators: Dow Pharmaceutical Sciences
Study start: Oct 2012
Primary completion: May 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 10 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ACYC	Active comparator	Drug: ACYCACYC active, topically applied to the face for 12 weeks
ACYC vehicle	Placebo comparator	Drug: ACYC vehicleACYC vehicle (placebo), topically applied to the face for 12 weeks

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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 (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACYCACYC active, topically applied to the face for 12 weeks	Drug	ACYC
ACYC vehicleACYC vehicle (placebo), topically applied to the face for 12 weeks	Drug	ACYC vehicle

Primary outcome

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

Results and safety

Results posted to the registry on 10 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACYC	253	243
ACYC Vehicle	245	236

Primary outcome: Absolute Change in Inflammatory Lesion Count

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: Lesion count

Measure	ACYC n = 253	ACYC Vehicle n = 245
Value	16.3 (9.75)	8.2 (11.55)

Primary outcome: Absolute Change in Non-inflammatory Lesion Count

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: lesion count

Measure	ACYC n = 253	ACYC Vehicle n = 245
Value	19.2 (16.18)	9.6 (17.49)

Primary outcome: Percent of Subjects Who Have a Least a 2 Grade Reduction

Time frame: Baseline and 12 Weeks. Number. Unit: Percent with >2% reduction

Measure	ACYC n = 253	ACYC Vehicle n = 245
Value	35.2	17

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

Time frame: Baseline and 12 Weeks. Number. Unit: percentage of clear or almost clear

Measure	ACYC n = 253	ACYC Vehicle n = 245
Value	28.5	14.5

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACYC	0 of 243 (0%)	38 of 243 (15.6%)	Not reported
ACYC Vehicle	0 of 236 (0%)	31 of 236 (13.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nilima Justice, M.D. study director

Medical Monitor, Valeant Pharmaceuticals

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ACYC in people with Acne, run by Bausch Health Americas, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in Inflammatory Lesion Count (time frame: Baseline and 12 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.