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

NCT03394235 | Completed DMC

• 1 other identifier: 007/2561
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia; Hair Loss/Baldness

Keywords

hair transplant; hairline; laser hair removal

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (1)

• Evaluate the changes in hair diameter at the treated sites.

  24 weeks

Study Arms (1)

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.

Device: Long-pulsed, 1064nm Nd-YAG laser

Interventions

Long-pulsed, 1064nm Nd-YAG laser DEVICE

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.

Long-pulsed, 1064nm Nd-YAG laser

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, aged 25-60 years with AGA or healthy
• Completed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead

Study Sites (1)

Institute of Dermatology

Bangkok, Thailand

Location

MeSH Terms

Conditions

Alopecia

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Chinmanat Tangjaturonrusamee, MD

  Institute of Dermatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 9, 2018
• Study Start: February 2, 2018
• Primary Completion: November 14, 2018
• Study Completion: January 16, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)