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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394235
Other study ID # 007/2561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2018
Est. completion date January 16, 2019

Study information

Verified date January 2019
Source Institute of Dermatology, Thailand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date January 16, 2019
Est. primary completion date November 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Thailand Institute of Dermatology Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Institute of Dermatology, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 24 weeks
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