search
Back to results

Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
topical 5% Minoxidil (Microneedling)
Sponsored by
Vancouver General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Men between the ages 18-65.
  2. Disease Stage: Norwood Hamilton IIIa-IV.
  3. Length of time with disease < 10 years.

Exclusion Criteria:

  1. Must not have other concurrent hair disease.
  2. Have not used any oral anti androgen (Finasteride or Dutasteride) in the past six months. If so, a washout period is needed. One month for Finasteride and three months for Dutasteride.
  3. Patients under the age of 18.
  4. Patients who are unable to offer consent.

Sites / Locations

  • The Skin Care CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microneedling

Arm Description

By randomization, the side for treatment will be determined. Topical anaesthetic will be then placed onto the treatment area under occlusion for thirty minutes to one hour. This will then be removed with 70% alcohol. The area will be rolled with microneedles in two planes: coronally and sagitally. In each plane, five passes will be made. Patients will restart application of Minoxidil the following day to both sides of the lesion. The same half of the scalp will be treated for the rest of the sessions, with topical anaesthetic applied by patient 30 minutes to an hour prior to start of treatment session. Patients will undergo microneedling on alternate weeks for a total of six treatments in 12 weeks. If there is >30% growth seen after six weeks, then the entire area will be treated.

Outcomes

Primary Outcome Measures

Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.

Secondary Outcome Measures

Adverse effects of the procedure will be recorded.

Full Information

First Posted
May 30, 2014
Last Updated
June 2, 2014
Sponsor
Vancouver General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02154503
Brief Title
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia
Official Title
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia- Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which has been limited with few options for medical and surgical treatment, the cost of the latter being prohibitive for many. Recently there have been several new modalities proposed as treatment, namely Microneedling and Platelet Rich Plasma. Microneedling has been shown to overexpress hair growth factors which may enhance or stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of topical products significantly. The exact mechanism of action of Microneedling is still being delineated. In this study, we aim to do a half lesional study with global photographs and hair counts done at the start of , week four and week twelve. Patients would be needled once weekly after application of topical anaesthetic (5% EMLA). If by week six there is significant regrowth (>30%), then total lesional needling will be done. Patients will only be using topical 5% Minoxidil throughout the study as this will prolong the effects of the regrowth.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microneedling
Arm Type
Experimental
Arm Description
By randomization, the side for treatment will be determined. Topical anaesthetic will be then placed onto the treatment area under occlusion for thirty minutes to one hour. This will then be removed with 70% alcohol. The area will be rolled with microneedles in two planes: coronally and sagitally. In each plane, five passes will be made. Patients will restart application of Minoxidil the following day to both sides of the lesion. The same half of the scalp will be treated for the rest of the sessions, with topical anaesthetic applied by patient 30 minutes to an hour prior to start of treatment session. Patients will undergo microneedling on alternate weeks for a total of six treatments in 12 weeks. If there is >30% growth seen after six weeks, then the entire area will be treated.
Intervention Type
Device
Intervention Name(s)
topical 5% Minoxidil (Microneedling)
Primary Outcome Measure Information:
Title
Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Adverse effects of the procedure will be recorded.
Time Frame
three months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men between the ages 18-65. Disease Stage: Norwood Hamilton IIIa-IV. Length of time with disease < 10 years. Exclusion Criteria: Must not have other concurrent hair disease. Have not used any oral anti androgen (Finasteride or Dutasteride) in the past six months. If so, a washout period is needed. One month for Finasteride and three months for Dutasteride. Patients under the age of 18. Patients who are unable to offer consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Shapiro, MD
Phone
6048755151
Email
jerry.shapiro@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Llorenia Muir-Green, MBBS
Phone
6048755151
Email
Llorenia.MuirGreen@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MBBS
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MD FRCPC

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

We'll reach out to this number within 24 hrs