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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01701024
Other study ID # V01-ACYC-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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