Effects of Acleara Needle Insert on Acne
Not Applicable
Completed
- Conditions
- Acne Vulgaris
- Registration Number
- NCT01677221
- Lead Sponsor
- Theravant Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Subject assessment of reduction in acne lesion size 24-72 hours, 1-2 weeks, 1 month Percentage range of lesion reduction
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Charles County Dermatology Associates
🇺🇸White Plains, Maryland, United States