Androgenetic AlopeciaNCT03394235
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter
A study testing Long-pulsed, 1064nm Nd-YAG laser in people with Androgenetic Alopecia and Hair Loss/Baldness, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial summary
This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the size of hair shaft diameter of the donor for hair transplantation. All participants will receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital area. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Hair Loss/Baldness
- What is being tested?
- Long-pulsed, 1064nm Nd-YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- 2 Feb 2018to 16 Jan 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, aged 25-60 years with AGA or healthy
- Completed informed consent form
Who cannot join
- Pregnancy or breastfeeding
- Acute infection on the scalp or any systemic infection
- Immunocompromised host
- Chronic wasting diseases
- Use of any medications which may affect hair loss such as anticoagulants, anti-hypertensive, hormones, anticonvulsants, retinoid, mood stabilizers and antidepressants
- Unstable medical problems which may affect hair loss such as thyroid diseases, autoimmune diseases, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, congestive heart failure, cerebrovascular accident and psychiatric problems
- Hair thinning at the occipital area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation
This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the size of hair shaft diameter of the donor for hair transplantation. All participants will receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital area.
Read the detailed description
Since the beginning of hair transplantation era, hair transplant technique has been greatly improved to achieve the best natural looking of hairline and hair density. Most Asians tend to have large size of hair shaft at the donor area, which often cause unnatural look of the hairline at the frontal area after hair transplantation due to the contrast between the transplanted hair and the original hair.
The idea of reducing the size of the hair shaft in the certain part of donor area before being transplanted to the frontal hairline becomes appealing. This transection is being practiced extensively in the field of cosmetic medicine by using long-pulsed Neodymium-Doped:Yttrium Aluminum Gamet (Nd:YAG), a laser treatment for permanent hair removal and vascular lesions.
- Conditions
- Androgenetic Alopecia, Hair Loss/Baldness
- Being tested
- Long-pulsed, 1064nm Nd-YAG laser
- Keywords
- hair transplant, hairline, laser hair removal
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-pulsed, 1064nm Nd-YAG laserDevice
This long-pulsed Nd-YAG laser is commonly used for laser hair removal and vascular lesions, but in this study it is used to reduce the size of the hair shaft at the occipital area.
| Study group | Role | What they receive |
|---|---|---|
| Long-pulsed, 1064nm Nd-YAG laser | Experimental | All participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area. Receives: Device: Long-pulsed, 1064nm Nd-YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the changes in hair density at the treated sites.
Evaluate changes in hair density at the treated sites following long-pulsed, 1064 Nd-YAG laser sessions every 8 weeks or until the treatment endpoint is reached before or at 24 weeks.
Measured: 24 weeks
Secondary outcomes (1)
Evaluate the changes in hair diameter at the treated sites.
Evaluate the changes in hair diameter at the treated sites following long-pulsed, 1064 Nd-YAG laser sessions every 8 weeks or until the treatment endpoint is reached before or at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start2 Feb 2018
- Primary completion14 Nov 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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
- Model description
- This is a pilot study. We plan to enroll 15 participants who requires to do hair transplantation or normal participants who are eligible for the study.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chinmanat Tangjaturonrusamee, MD, Study director, Institute of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394235
- Sponsor's protocol ID
- 007/2561
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not stated in participants' informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation
- ClinicalTrials.gov ID
- NCT03394235
- Acronym / sponsor ID
- 007/2561
- Conditions
- Androgenetic Alopecia, Hair Loss/Baldness
- Keywords
- hair transplant, hairline, laser hair removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 9 Jan 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.
This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the size of hair shaft diameter of the donor for hair transplantation. All participants will receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital area.
Detailed description
Since the beginning of hair transplantation era, hair transplant technique has been greatly improved to achieve the best natural looking of hairline and hair density. Most Asians tend to have large size of hair shaft at the donor area, which often cause unnatural look of the hairline at the frontal area after hair transplantation due to the contrast between the transplanted hair and the original hair.
The idea of reducing the size of the hair shaft in the certain part of donor area before being transplanted to the frontal hairline becomes appealing. This transection is being practiced extensively in the field of cosmetic medicine by using long-pulsed Neodymium-Doped:Yttrium Aluminum Gamet (Nd:YAG), a laser treatment for permanent hair removal and vascular lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study. We plan to enroll 15 participants who requires to do hair transplantation or normal participants who are eligible for the study.
| Arm | Type | Receives |
|---|---|---|
| Long-pulsed, 1064nm Nd-YAG laser | Experimental | Device: Long-pulsed, 1064nm Nd-YAG laserAll participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, aged 25-60 years with AGA or healthy
- Completed informed consent form
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Acute infection on the scalp or any systemic infection
- Immunocompromised host
- Chronic wasting diseases
- Use of any medications which may affect hair loss such as anticoagulants, anti-hypertensive, hormones, anticonvulsants, retinoid, mood stabilizers and antidepressants
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 |
|---|---|---|
| Long-pulsed, 1064nm Nd-YAG laserThis long-pulsed Nd-YAG laser is commonly used for laser hair removal and vascular lesions, but in this study it is used to reduce the size of the hair shaft at the occipital area. | Device | Long-pulsed, 1064nm Nd-YAG laser |
Primary outcome
Evaluate the changes in hair density at the treated sites.
Time frame: 24 weeks
Evaluate changes in hair density at the treated sites following long-pulsed, 1064 Nd-YAG laser sessions every 8 weeks or until the treatment endpoint is reached before or at 24 weeks.
1 secondary outcome
Evaluate the changes in hair diameter at the treated sites.
Time frame: 24 weeks
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 30 Jan 2019.
- Individual participant dataSharing planned: No. Individual participant data is not stated in participants' informed consent.
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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.
Chinmanat Tangjaturonrusamee, MD study director
Institute of 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 Long-pulsed, 1064nm Nd-YAG laser in people with Androgenetic Alopecia and Hair Loss/Baldness, run by Institute of Dermatology, Thailand at 1 site in Thailand.
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 2 inclusion and 7 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 30 Jan 2019. 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 Thailand. 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?
Evaluate the changes in hair density at the treated sites. (time frame: 24 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 30 Jan 2019.