Back to resultsEffects of Acleara Needle Insert on Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acleara Acne Treatment System
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, inflammatory acne, intense pulsed light
Eligibility 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.
Sites / Locations
- Charles County Dermatology Associates
- Bellaire Dermatology Associates
Outcomes
Primary Outcome Measures
Subject assessment of reduction in acne lesion size
Percentage range of lesion reduction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01677221
Brief Title
Effects of Acleara Needle Insert on Acne
Official Title
A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravant Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, inflammatory acne, intense pulsed light
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Acleara Acne Treatment System
Primary Outcome Measure Information:
Title
Subject assessment of reduction in acne lesion size
Description
Percentage range of lesion reduction
Time Frame
24-72 hours, 1-2 weeks, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Charles County Dermatology Associates
City
White Plains
State/Province
Maryland
ZIP/Postal Code
20695-3064
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
12. IPD Sharing Statement
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Effects of Acleara Needle Insert on Acne
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