- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394235
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bangkok, Thailand
- Institute of dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women, aged 25-60 years with AGA or healthy
- Completed informed consent form
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Long-pulsed, 1064nm Nd-YAG laser
All participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate the changes in hair density at the treated sites.
Time Frame: 24 weeks
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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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the changes in hair diameter at the treated sites.
Time Frame: 24 weeks
|
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.
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24 weeks
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Collaborators and Investigators
Investigators
- Study Director: Chinmanat Tangjaturonrusamee, MD, Institute of dermatology
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 007/2561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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