Effects of Acleara Needle Insert on Acne

January 9, 2013 updated by: Theravant Corporation

A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris

This prospective, open-label study will be conducted in 15 healthy subjects per clinical site ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5 lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • White Plains, Maryland, United States, 20695-3064
        • Charles County Dermatology Associates
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects >14 years of age
  • Subject has mild to moderate acne vulgaris on the face, chest or back.
  • Subject has one or more inflammatory acne lesions on face, chest or back.
  • Willingness to participate in the study
  • Informed consent agreement signed by the subject
  • Willingness to follow the treatment schedule and post treatment care requirements
  • Willingness to remain on current acne therapy as directed by the Investigator.

Exclusion Criteria:

  • Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
  • Subject is immunosuppressed
  • Subject is unable to comply with treatment or follow-up visits
  • Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject assessment of reduction in acne lesion size
Time Frame: 24-72 hours, 1-2 weeks, 1 month
Percentage range of lesion reduction
24-72 hours, 1-2 weeks, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravant Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acleara-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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