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Effects of Acleara Needle Insert on Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01677221
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Acne Vulgaris Device: Acleara Acne Treatment System

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris
Study Start Date : July 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Subject assessment of reduction in acne lesion size [ Time Frame: 24-72 hours, 1-2 weeks, 1 month ]
    Percentage range of lesion reduction


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677221


Locations
United States, Maryland
Charles County Dermatology Associates
White Plains, Maryland, United States, 20695-3064
United States, Texas
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Theravant Corporation
More Information

Responsible Party: Theravant Corporation
ClinicalTrials.gov Identifier: NCT01677221     History of Changes
Other Study ID Numbers: Acleara-01
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Theravant Corporation:
acne
inflammatory acne
intense pulsed light

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents