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Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter

Primary Purpose

Androgenetic Alopecia, Hair Loss/Baldness

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Long-pulsed, 1064nm Nd-YAG laser
Sponsored by
Institute of Dermatology, Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring hair transplant, hairline, laser hair removal

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-pulsed, 1064nm Nd-YAG laser

Arm Description

All participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 2, 2018
Last Updated
January 29, 2019
Sponsor
Institute of Dermatology, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT03394235
Brief Title
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter
Official Title
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
January 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Dermatology, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Hair Loss/Baldness
Keywords
hair transplant, hairline, laser hair removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long-pulsed, 1064nm Nd-YAG laser
Arm Type
Experimental
Arm Description
All participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area.
Intervention Type
Device
Intervention Name(s)
Long-pulsed, 1064nm Nd-YAG laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the changes in hair density at the treated sites.
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Evaluate the changes in hair diameter at the treated sites.
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinmanat Tangjaturonrusamee, MD
Organizational Affiliation
Institute of Dermatology
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Dermatology
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data is not stated in participants' informed consent.

Learn more about this trial

Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter

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