Effects of Acleara Needle Insert on Acne

Acne Vulgaris Clinical Trial

Official title:

A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677221
• Other study ID #: Acleara-01
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: January 9, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Theravant Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Acleara Acne Treatment System

Locations

Country	Name	City	State
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Charles County Dermatology Associates	White Plains	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Theravant Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject assessment of reduction in acne lesion size	Percentage range of lesion reduction	24-72 hours, 1-2 weeks, 1 month