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

Acne Clinical Trial

— ACYC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701024
• Other study ID #: V01-ACYC-301
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: May 2018
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• ACYC
ACYC active, topically applied to the face for 12 weeks
• ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.	Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

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