Acne Vulgaris
Conditions
Keywords
acne, inflammatory acne, intense pulsed light
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.
Interventions
DEVICEAcleara Acne Treatment System
Sponsors
Theravant Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject assessment of reduction in acne lesion size | 24-72 hours, 1-2 weeks, 1 month | Percentage range of lesion reduction |
Countries
United States
Outcome results
None listed