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

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ClinicalTrials.gov Identifier: NCT03394235
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Dermatology, Thailand

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Hair Loss/Baldness Device: Long-pulsed, 1064nm Nd-YAG laser Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


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.
Device: Long-pulsed, 1064nm Nd-YAG laser
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394235


Contacts
Contact: Chinmanat Tangjaturonrusamee, MD +66-2-354-5222 hairmaximizer@gmail.com

Locations
Thailand
Institute of Dermatology Recruiting
Bangkok, Thailand
Contact: Chinmanat Tangjaturonrusamee, M.D.         
Sponsors and Collaborators
Institute of Dermatology, Thailand
Investigators
Study Director: Chinmanat Tangjaturonrusamee, MD Institute of Dermatology

Responsible Party: Institute of Dermatology, Thailand
ClinicalTrials.gov Identifier: NCT03394235     History of Changes
Other Study ID Numbers: 007/2561
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is not stated in participants' informed consent.

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

Keywords provided by Institute of Dermatology, Thailand:
hair transplant
hairline
laser hair removal

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical