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

• ClinicalTrials.gov Identifier: NCT03394235
• Recruitment Status: Completed
• First Posted: January 9, 2018
• Last Update Posted: January 30, 2019
• Sponsor: Institute of Dermatology, Thailand
• Information provided by (Responsible Party): Institute of Dermatology, Thailand

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: November 14, 2018
• Actual Study Completion Date: January 16, 2019

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Thailand

Institute of Dermatology

Bangkok, Thailand

Sponsors and Collaborators

Institute of Dermatology, Thailand

Investigators

• Study Director: Chinmanat Tangjaturonrusamee, MD; Institute of Dermatology

More Information

• Responsible Party: Institute of Dermatology, Thailand
• ClinicalTrials.gov Identifier: NCT03394235
• Other Study ID Numbers: 007/2561
• First Posted: January 9, 2018
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

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