Acne VulgarisNCT01677221
Effects of Acleara Needle Insert on Acne
A study testing Acleara Acne Treatment System in people with Acne Vulgaris, run by Theravant Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Acleara Acne Treatment System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Charles County Dermatology Associates
White Plains, Maryland, 20695-3064
About this study
Official title: A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris
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.
- Conditions
- Acne Vulgaris
- Being tested
- Acleara Acne Treatment System
- Keywords
- acne, inflammatory acne, intense pulsed light
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acleara Acne Treatment SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject assessment of reduction in acne lesion size
Percentage range of lesion reduction
Measured: 24-72 hours, 1-2 weeks, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677221
- Sponsor's protocol ID
- Acleara-01
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01677221
- Acronym / sponsor ID
- Acleara-01
- Conditions
- Acne Vulgaris
- Keywords
- acne, inflammatory acne, intense pulsed light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Theravant CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acleara Acne Treatment System | Device | – |
Primary outcome
Subject assessment of reduction in acne lesion size
Time frame: 24-72 hours, 1-2 weeks, 1 month
Percentage range of lesion reduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acleara Acne Treatment System in people with Acne Vulgaris, run by Theravant Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject assessment of reduction in acne lesion size (time frame: 24-72 hours, 1-2 weeks, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.