HirsutismNCT00495443
Enhanced Safety Aesthetic Laser System
A study testing Peterio in people with Hirsutism and Hypertrichosis, run by Scilex Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hirsutism, Hypertrichosis, Telangiectases
- What is being tested?
- Peterio
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Sep 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old
- Fitzpatrick skin types I to VI
- Unwanted hair or/and
- Aesthetically disturbing vascular lesions or/and
- Facial rhytides
Who cannot join
- Age below 18 or above 75 year old.
- Use of photosensitive medications
- Photosensitive diseases
- Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
- Exposure to sun or artificial tanning during the last 3-4 weeks
- For treatment of facial rhytides- surgical or nonsurgical facial procedure (i.e., laser skin resurfacing, dermabrasion, phenol peel, nonablative laser, or temporary/permanent filler (e.g., collagen, fat, hyaluronic acid injections)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Center, Dermatology
Jerusalem, 91120
Leon Gilad, MD
About this study
Official title: Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments
The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides.
Read the detailed description
Cosmetic lasers are a well-established, popular modality for removal of unwanted hair, treatment of all types of vascular lesions, including hemangiomas, port wine stains, and a variety of telangiectases as well as facial rhytides reduction. The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle, where the energy is converted to heat resulting in a thermal injury. However, the lasers for cosmetic treatments are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. Similar problem exists when targeting other chromophores such as hemoglobin or water. The purpose of the study is an evaluation of safety and efficacy of a new laser based device.
- Conditions
- Hirsutism, Hypertrichosis, Telangiectases, Rhytides
- Being tested
- Peterio
- Medical subject headings
- Hirsutism, Hypertrichosis, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeterioDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.
Secondary outcomes (1)
Measuring treatment discomfort as graded by the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startSep 2007
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HirsutismStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scilex Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leon Gilad, MD, Principal investigator, Hadassah Medical Center, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495443
- Sponsor's protocol ID
- Peterio-06
- Status last verified
- Jul 2007
- First submitted
- 1 Jul 2007
- Last updated
- 3 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
PubMed 6836297
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments
- ClinicalTrials.gov ID
- NCT00495443
- Acronym / sponsor ID
- Peterio-06
- Conditions
- Hirsutism, Hypertrichosis, Telangiectases, Rhytides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Scilex Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Sep 2008 (estimated)
- First posted
- 3 Jul 2007 (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.
The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides.
Detailed description
Cosmetic lasers are a well-established, popular modality for removal of unwanted hair, treatment of all types of vascular lesions, including hemangiomas, port wine stains, and a variety of telangiectases as well as facial rhytides reduction. The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle, where the energy is converted to heat resulting in a thermal injury. However, the lasers for cosmetic treatments are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. Similar problem exists when targeting other chromophores such as hemoglobin or water. The purpose of the study is an evaluation of safety and efficacy of a new laser based device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years old
- Fitzpatrick skin types I to VI
- Unwanted hair or/and
- Aesthetically disturbing vascular lesions or/and
- Facial rhytides
Key exclusion criteria (6 listed)
- Age below 18 or above 75 year old.
- Use of photosensitive medications
- Photosensitive diseases
- Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
- Exposure to sun or artificial tanning during the last 3-4 weeks
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 |
|---|---|---|
| Peterio | Device | – |
Primary outcome
Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.
1 secondary outcome
Measuring treatment discomfort as graded by the patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
- Background: PubMed 6836297Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
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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.
Leon Gilad, MD principal investigator
Hadassah Medical Center, Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peterio in people with Hirsutism and Hypertrichosis, run by Scilex 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 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Rapoport, BSC (972-39506949, alecr@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495443, which also lists 1 linked publication.
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 3 Jul 2007.