NCT01701024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 10, 2017

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

September 27, 2012

Results QC Date

January 15, 2015

Last Update Submit

May 2, 2018

Conditions

Acne

Keywords

Acne

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

ACYC

ACTIVE COMPARATOR

ACYC active, topically applied to the face for 12 weeks

Drug: ACYC

ACYC vehicle

PLACEBO COMPARATOR

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

Drug: ACYC vehicle

Interventions

ACYCDRUG

ACYC active, topically applied to the face for 12 weeks

ACYC
ACYC vehicleDRUG

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

ACYC vehicle

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Mobile, Alabama, 36608, United States

Location

Unknown Facility

Los Angeles, California, 90045, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

New Haven, Connecticut, 06511, United States

Location

Unknown Facility

Aventura, Florida, 33180, United States

Location

Unknown Facility

Naperville, Illinois, 60563, United States

Location

Unknown Facility

Evansville, Indiana, 47714, United States

Location

Unknown Facility

South Bend, Indiana, 46617, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Clinton Township, Michigan, 48038, United States

Location

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Omaha, Nebraska, 68144, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Rochester, New York, 14623, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Goodlettsville, Tennessee, 37072, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

College Station, Texas, 77845, United States

Location

Unknown Facility

Houston, Texas, 77056, United States

Location

Unknown Facility

San Antonio, Texas, 78250, United States

Location

Unknown Facility

Salt Lake City, Utah, 84117, United States

Location

Unknown Facility

Lynchburg, Virginia, 24501, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Johnson Varughese
Organization
Exec Dir Clinical Dir
johnson.varughese@valeant.com
908-927-1162

Study Officials

  • Nilima Justice, M.D.

    Medical Monitor, Valeant Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 4, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

June 4, 2018

Results First Posted

January 10, 2017

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Locations

US(24)