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OpenTrials
Completed

NCT Number: NCT01677221

Effects of Acleara Needle Insert on Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles County Dermatology Associates, White Plains, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acleara Acne Treatment System

Device

Primary outcomes

  1. Subject assessment of reduction in acne lesion size

    Time frame: 24-72 hours, 1-2 weeks, 1 month

    Percentage range of lesion reduction

Sponsors and collaborators

Lead sponsor

Theravant Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2012
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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