Effects of Acleara Needle Insert on Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravant Corporation
ClinicalTrials.gov Identifier:
NCT01677221
First received: August 29, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention
Acne Vulgaris
Device: Acleara Acne Treatment System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Theravant Corporation:

Primary Outcome Measures:
  • Subject assessment of reduction in acne lesion size [ Time Frame: 24-72 hours, 1-2 weeks, 1 month ] [ Designated as safety issue: No ]
    Percentage range of lesion reduction


Enrollment: 30
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Theravant Corporation
ClinicalTrials.gov Identifier: NCT01677221     History of Changes
Other Study ID Numbers: Acleara-01
Study First Received: August 29, 2012
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014