NCT01677221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

August 29, 2012

Last Update Submit

January 9, 2013

Conditions

Acne Vulgaris

Keywords

acneinflammatory acneintense pulsed light

Outcome Measures

Primary Outcomes (1)

  • Subject assessment of reduction in acne lesion size

    Percentage range of lesion reduction

    24-72 hours, 1-2 weeks, 1 month

Interventions

Acleara Acne Treatment SystemDEVICE

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charles County Dermatology Associates

White Plains, Maryland, 20695-3064, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(2)