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The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.

Primary Purpose

Dermatologic Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
accupuncture
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatologic Disease

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

- androgenic alopecia patients

Exclusion Criteria:

  • infection, immune disorder, other dermatosis in treating areas

Sites / Locations

  • ShinKongHospital

Outcomes

Primary Outcome Measures

hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).)
hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).)

Secondary Outcome Measures

Full Information

First Posted
October 24, 2018
Last Updated
December 30, 2019
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03723369
Brief Title
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.
Official Title
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Androgenetic alopecia is the most common type of hair loss in men, and affects approximately 50 percent of Caucasian men by age 50. The condition is characterized by the progressive loss of terminal hairs on the scalp in a characteristic distribution. The anterior scalp, mid scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. "Male balding" and "male pattern hair loss" are additional terms used to refer to this condition. The aim of this study is to investigate the effect of microneedling in androgenic alopecia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
accupuncture
Intervention Description
accupuncture
Primary Outcome Measure Information:
Title
hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).)
Description
hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).)
Time Frame
12weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
androgenic alopecia
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - androgenic alopecia patients Exclusion Criteria: infection, immune disorder, other dermatosis in treating areas
Facility Information:
Facility Name
ShinKongHospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.

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