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

August 29, 2012
January 9, 2013
July 2012
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01677221 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Acleara Needle Insert on Acne
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acne Vulgaris
Device: Acleara Acne Treatment System
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677221
Acleara-01
No
Theravant Corporation
Theravant Corporation
Not Provided
Not Provided
Theravant Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP