EpilationPhase 1/2NCT00348257
Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
A Phase 1/2 study testing Hair removal by laser/IPL device in people with Epilation, run by Leortec Medical Systems Ltd at 1 site in Israel.
Trial summary
Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair removal, and thus require extensive maintenance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilation
- What is being tested?
- Hair removal by laser/IPL device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to Sep 2006
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males/females between the ages of 18 to 70
- Subject is willing to go trough hair removal treatment.
- Subject understands the study procedure.
- Subject is willing to sign the inform consent.
- Subject must have the ability to comply with the study procedures and follow- up.
Who cannot join
- Age < 18 years or > 70 years.
- Use of medication for which 400nm to 1400nm light exposure is contraindicated
- Coagulation disorder.
- Infection / abscess / pains in treatment target area.
- Recently tanned skin.
- Photosensitivity or allergy.
Show all 19Show fewer
- Psoriasis.
- Skin cancer.
- Diabetes.
- Pregnancy.
- Tattoo on targeted area.
- History of keloid scarring.
- Use of aspirin or antioxidants
- Eczema or dermatitis.
- Subject is suffering extreme general weakness.
- Subject objects to the study protocol.
- Physician objection.
- Known cognitive or psychiatric disorder
- Participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair removal, and thus require extensive maintenance. Long term hair removal via electrolysis is generally unsatisfactory due to its time consuming, painful nature and the associated risk of scarring or pigmentary changes. Moreover, the efficacy of electrolysis is user dependent and is estimated to be reduction of only 15-50% of the unwanted hair3.
The more modern approach to long term hair removal involves laser and Intense Pulsed Light (IPL) treatment modalities. These technologies are based on the scientific principle of selective photothermolysis. During the treatment, the light energy is absorbed by the hair's pigment (melanin) and transmitted through the hair shaft to the follicle. Conversion of this energy into heat causes a rise in the hair temperature, leading to destruction of the follicle and disruption of the hair growth mechanism, while leaving the skin undamaged.
Both laser and light devices have been proven successful in inducing permanent hair removal, as well as delayed hair growth, while causing minimal discomfort and complications. The light devices are based on the IPL technology, which differs from laser light in various physical aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL delivers a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of this study is to evaluate the safety and efficacy of using Leortec 300 device for hair removal treatment.
Read the detailed description
STUDY OBJECTIVES
- Primary Objective
- Safety
- To evaluate the safety of using LEORTEC-300 System for hair removal treatment, in different skin/hair colors and anatomical sites.
- Secondary Objectives
- Effectiveness
- To assess the effectiveness of using the LEORTEC-300 system for hair removal treatment in different skin/hair colors and anatomical sites.
- Patient Satisfaction Immediately after the treatment patients will be asked to rate pain level which they felt during the treatment.
- Physician's Satisfaction Physician's satisfaction from the technique, equipment and hair removal will be assessed by physician's questionnaire.
STUDY DESIGN
This is a two-sites, prospective, controlled study to further test the safety and effectiveness of the LEORTEC-300 system in hair removal treatment.
SUBJECTS
1.Source and Number Subjects for the study will be recruited from patients within the community who have sought treatment for hair removal from the investigative physicians and meet all of the eligibility criteria listed below. There will be a total of 30 patients.
- Conditions
- Epilation
- Being tested
- Hair removal by laser/IPL device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair removal by laser/IPL deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
N2 - Average number of hairs before the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Leortec Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanna Levy, PhD, Study director, Leortec Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348257
- Sponsor's protocol ID
- LEORTC-HR-001
- Status last verified
- Feb 2007
- First submitted
- 2 Jul 2006
- Last updated
- 28 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
- ClinicalTrials.gov ID
- NCT00348257
- Acronym / sponsor ID
- LEORTC-HR-001
- Conditions
- Epilation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Leortec Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Sep 2006
- First posted
- 4 Jul 2006 (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.
Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair removal, and thus require extensive maintenance. Long term hair removal via electrolysis is generally unsatisfactory due to its time consuming, painful nature and the associated risk of scarring or pigmentary changes. Moreover, the efficacy of electrolysis is user dependent and is estimated to be reduction of only 15-50% of the unwanted hair3.
The more modern approach to long term hair removal involves laser and Intense Pulsed Light (IPL) treatment modalities. These technologies are based on the scientific principle of selective photothermolysis. During the treatment, the light energy is absorbed by the hair's pigment (melanin) and transmitted through the hair shaft to the follicle. Conversion of this energy into heat causes a rise in the hair temperature, leading to destruction of the follicle and disruption of the hair growth mechanism, while leaving the skin undamaged.
Both laser and light devices have been proven successful in inducing permanent hair removal, as well as delayed hair growth, while causing minimal discomfort and complications. The light devices are based on the IPL technology, which differs from laser light in various physical aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL delivers a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of this study is to evaluate the safety and efficacy of using Leortec 300 device for hair removal treatment.
Detailed description
STUDY OBJECTIVES
- Primary Objective
- Safety
- To evaluate the safety of using LEORTEC-300 System for hair removal treatment, in different skin/hair colors and anatomical sites.
- Secondary Objectives
- Effectiveness
- To assess the effectiveness of using the LEORTEC-300 system for hair removal treatment in different skin/hair colors and anatomical sites.
- Patient Satisfaction Immediately after the treatment patients will be asked to rate pain level which they felt during the treatment.
- Physician's Satisfaction Physician's satisfaction from the technique, equipment and hair removal will be assessed by physician's questionnaire.
STUDY DESIGN
This is a two-sites, prospective, controlled study to further test the safety and effectiveness of the LEORTEC-300 system in hair removal treatment.
SUBJECTS
1.Source and Number Subjects for the study will be recruited from patients within the community who have sought treatment for hair removal from the investigative physicians and meet all of the eligibility criteria listed below. There will be a total of 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males/females between the ages of 18 to 70
- Subject is willing to go trough hair removal treatment.
- Subject understands the study procedure.
- Subject is willing to sign the inform consent.
- Subject must have the ability to comply with the study procedures and follow- up.
Key exclusion criteria (19 listed)
- Age < 18 years or > 70 years.
- Use of medication for which 400nm to 1400nm light exposure is contraindicated
- Coagulation disorder.
- Infection / abscess / pains in treatment target area.
- Recently tanned skin.
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 |
|---|---|---|
| Hair removal by laser/IPL device | Device | – |
Primary outcome
Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
N2 - Average number of hairs before the treatment)
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 28 Feb 2007.
Related trials for Epilation
Recruiting
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Pilonidal Disease
Not yet recruiting
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Microbial Contamination, Environmental Contamination
Active, not recruitingPhase 4
Ice Versus EMLA for Pain in Laser Hair Removal
Hair Removal
Not yet recruiting
A Comparative Study of the Antibacterial Effects of Two Preoperative Hair Removal Methods in Male Patients With Urethral Stricture
Urethral Stricture
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.
Hanna Levy, PhD study director
Leortec Medical Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hair removal by laser/IPL device in people with Epilation, run by Leortec Medical Systems Ltd at 1 site in Israel.
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 5 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 28 Feb 2007. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment. The study lists 2 primary outcomes in all. 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 28 Feb 2007.