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Completed

NCT Number: NCT01701024

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

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mobile, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACYC

Drug

ACYC active, topically applied to the face for 12 weeks

ACYC vehicle

Drug

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

Primary outcomes

  1. Absolute Change in Inflammatory Lesion Count

    Time frame: Baseline and 12 Weeks

  2. Absolute Change in Non-inflammatory Lesion Count

    Time frame: Baseline and 12 Weeks

  3. Percent of Subjects Who Have a Least a 2 Grade Reduction

    Time frame: Baseline and 12 Weeks

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

    Time frame: Baseline and 12 Weeks

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Dow Pharmaceutical Sciences

Registry information

Official study 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

Acronym: ACYC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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