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
About this trial
This is an interventional treatment trial for Dermatologic Disease
Eligibility Criteria
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
NCT ID
NCT03723369
First Posted
October 24, 2018
Last Updated
December 30, 2019
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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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