Laser Hair RemovalNCT00657085
Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
An observational study of Laser Hair Removal, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Laser Hair Removal
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2008
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 5 Adult male subjects that have sought laser back hair removal
Who may be able to join
- Healthy male adult, 18 years of age or older with skin type I-V;
- Having a suitable treatment area for hair removal with brown or black hair (no gray);
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to read, understand and provide written Informed Consent.
Who cannot join
- Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
- Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- Adverse reaction to the treatment gel to be used in the evaluation;
- History of keloid formation or poor wound healing in a previously injured skin area;
- Significant skin conditions affecting treated area or inflammatory skin conditions;
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- Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated;
- Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
- Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
- Photosensitivity disorder that can be exacerbated by infrared light;
- Tattoos in the treatment areas;
- Dysplastic nevi in the treatment areas;
- Allergy or history of an allergy to the topical anesthetic used.
- Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
Trial locations and contacts
1 site in 1 country.
About this study
To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.
- Conditions
- Laser Hair Removal
- Keywords
- Laser hair removal
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular damage assessed by histology
Measured: first visit
Secondary outcomes (1)
Comparison of permanent hair reduction between ET and HS handpieces
Measured: 2 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Hair RemovalStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seaver Soon, MD, Principal investigator, Scripps Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657085
- Sponsor's protocol ID
- LUM-ABU-HSET-0607-02
- Status last verified
- Dec 2008
- First submitted
- 8 Apr 2008
- Last updated
- 12 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
- ClinicalTrials.gov ID
- NCT00657085
- Acronym / sponsor ID
- LUM-ABU-HSET-0607-02
- Conditions
- Laser Hair Removal
- Keywords
- Laser hair removal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Apr 2008 (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.
To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 5 Adult male subjects that have sought laser back hair removal
Key inclusion criteria (4 listed)
- Healthy male adult, 18 years of age or older with skin type I-V;
- Having a suitable treatment area for hair removal with brown or black hair (no gray);
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to read, understand and provide written Informed Consent.
Key exclusion criteria (19 listed)
- Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
- Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- Adverse reaction to the treatment gel to be used in the evaluation;
- History of keloid formation or poor wound healing in a previously injured skin area;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follicular damage assessed by histology
Time frame: first visit
1 secondary outcome
Comparison of permanent hair reduction between ET and HS handpieces
Time frame: 2 month follow up visit
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 12 Dec 2008.
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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.
Seaver Soon, MD principal investigator
Scripps Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laser Hair Removal, run by Lumenis Be Ltd. at 1 site 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 4 inclusion and 19 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 12 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Follicular damage assessed by histology (time frame: first visit). 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 12 Dec 2008.