Hair RemovalNCT03438929
Evaluation of Diolaze XL Blended Mode for Hair Removal
A study testing Diode laser in people with Hair Removal, run by InMode MD Ltd. at 1 site in Israel.
Trial summary
The objective of this clinical study is to evaluate safety and efficiency of Diolase XL blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and 810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled. Treatment sites will be o groins and axillae. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Removal
- What is being tested?
- Diode laser
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Aug 2017to 10 Feb 2018
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult females between the ages of 18-65, seeking hair removal treatments.
- Subjects skin type II-V.
- Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- Subjects should be willing to comply with the study procedure and schedule, including the follow up visit, to refrain from using any other aesthetic treatment methods in the treatment areas such as other hair removal methods (wax, IPL, laser), Botox or other technologies for hyperhidrosis or rejuvenation for the last 6 months and during the entire study period and to remain unshaven for a minimum of 3 days before their visit.
Who cannot join
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
- Pregnancy and nursing.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
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- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- Known skin photosensitivity or using drugs increasing skin photosensitivity.
- Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
- Six months delay is recommended if other recent treatments like light, laser or RF were performed on the same area.
- Treating over tattoo and permanent make-up.
- Fresh tan from sun, sunbeds or chemicals or planned excessive sun exposure.
- Vitiligo.
- As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Diolaze XL Blended Mode for Hair Removal
The objective of this clinical study is to evaluate safety and efficiency of Diolase XL blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and 810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled. Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4 weeks apart and follow-up after 3 months.
- Conditions
- Hair Removal
- Being tested
- Diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Diolaze XL blended modes diode laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair reduction
Hair reduction of at least 30% at follow-up visit comparing to baseline count.
Measured: 3 months follow-up
Recording of frequency, severity and causality of adverse events (Safety)
Observation, assessment and recording of reactions by the investigator.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start14 Aug 2017
- Primary completion30 Jan 2018
- Study completion10 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hela Goren, Ph.D., Study director, InMode MD Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438929
- Sponsor's protocol ID
- DO607227A
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Diolaze XL Blended Mode for Hair Removal
- ClinicalTrials.gov ID
- NCT03438929
- Acronym / sponsor ID
- DO607227A
- Conditions
- Hair Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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 objective of this clinical study is to evaluate safety and efficiency of Diolase XL blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and 810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled. Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4 weeks apart and follow-up after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult females between the ages of 18-65, seeking hair removal treatments.
- Subjects skin type II-V.
- Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- Subjects should be willing to comply with the study procedure and schedule, including the follow up visit, to refrain from using any other aesthetic treatment methods in the treatment areas such as other hair removal methods (wax, IPL, laser), Botox or other technologies for hyperhidrosis or rejuvenation for the last 6 months and during the entire study period and to remain unshaven for a minimum of 3 days before their visit.
Key exclusion criteria (16 listed)
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
- Pregnancy and nursing.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization.
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 |
|---|---|---|
| Diode laserDiolaze XL blended modes diode laser | Device | – |
Primary outcome
Hair reduction
Time frame: 3 months follow-up
Hair reduction of at least 30% at follow-up visit comparing to baseline count.
Recording of frequency, severity and causality of adverse events (Safety)
Time frame: 3 months follow-up
Observation, assessment and recording of reactions by the investigator.
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 22 May 2018.
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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.
Hela Goren, Ph.D. study director
InMode MD Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser in people with Hair Removal, run by InMode MD 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 4 inclusion and 16 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 22 May 2018. 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?
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 reduction (time frame: 3 months follow-up). 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 22 May 2018.