HypertrichosisNCT02536092
A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
A study testing 755nm and 1064nm Nd:YAG laser in people with Hypertrichosis, run by Cutera Inc. at 2 sites in Canada.
Trial summary
To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrichosis
- What is being tested?
- 755nm and 1064nm Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2015to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI (Appendix 3).
- Subject has black or dark brown unwanted hair.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
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- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Must agree not to use hair removal products, such as topical chemical depilatories, or undergo any other hair removal procedure during the study, such as other laser and light therapies or waxing.
- Willing to refrain from excess sun exposure and willing to wear sunscreen on the treatment area during the study (including the follow-up period).
- Be in good health, as determined by the Investigator.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
- Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
- Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study
- History of malignant tumors in the target area.
- Pregnant and/or breastfeeding.
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- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
- Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Current smoker or history of smoking within 6 months of study participation.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Lezara Laser & Vein Care
Squamish, British Columbia, V5B0C1
Body Bar Laser Clinic/Academy
Surrey, British Columbia, V4P1B7
About this study
To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.
Read the detailed description
This is a multi-center prospective, open-label, uncontrolled multi-center study of up to 50 male or female subjects, age 18 to 65 years, who desire laser hair removal. Subjects will receive 6 hair removal treatments, spaced 8 weeks apart, and will be followed at 12 weeks post-final treatment.
- Conditions
- Hypertrichosis
- Being tested
- 755nm and 1064nm Nd:YAG laser
- Medical subject headings
- Hypertrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755nm and 1064nm Nd:YAG laserDevice
Also called Excel HR
Dual wavelength 755nm and 1064nm Nd:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| 755nm and 1064nm Nd:YAG laser | Experimental | 755nm and 1064nm Nd:YAG laser Receives: Device: 755nm and 1064nm Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment
Percentage of hair reduction
Measured: 12 weeks
Secondary outcomes (1)
Incidence and severity of adverse device effects
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Sponsor terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrichosisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536092
- Sponsor's protocol ID
- C-15-HR-03
- Status last verified
- Jan 2023
- First submitted
- 27 Aug 2015
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
- ClinicalTrials.gov ID
- NCT02536092
- Acronym / sponsor ID
- C-15-HR-03
- Conditions
- Hypertrichosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Aug 2015 (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 evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.
Detailed description
This is a multi-center prospective, open-label, uncontrolled multi-center study of up to 50 male or female subjects, age 18 to 65 years, who desire laser hair removal. Subjects will receive 6 hair removal treatments, spaced 8 weeks apart, and will be followed at 12 weeks post-final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 755nm and 1064nm Nd:YAG laser | Experimental | Device: 755nm and 1064nm Nd:YAG laser755nm and 1064nm Nd:YAG laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI (Appendix 3).
- Subject has black or dark brown unwanted hair.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
Key exclusion criteria (21 listed)
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
- Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
- Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study
- History of malignant tumors in the target area.
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 |
|---|---|---|
| 755nm and 1064nm Nd:YAG laserAlso: Excel HRDual wavelength 755nm and 1064nm Nd:YAG laser | Device | 755nm and 1064nm Nd:YAG laser |
Primary outcome
Physician's Global Assessment
Time frame: 12 weeks
Percentage of hair reduction
1 secondary outcome
Incidence and severity of adverse device effects
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No. Study terminated
Related trials for Hypertrichosis
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
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 755nm and 1064nm Nd:YAG laser in people with Hypertrichosis, run by Cutera Inc. at 2 sites in Canada.
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 11 inclusion and 21 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: withdrawn, as of the sponsor's last update on 26 Jan 2023. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Physician's Global Assessment (time frame: 12 weeks). 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 26 Jan 2023.