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Microneedling for Male Pattern Baldness

Phase 1
Waitlist Available
Led By Jerry Shapiro, MBBS
Research Sponsored by Vancouver General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months
Awards & highlights

Study 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.

Eligible Conditions
  • Male Pattern Baldness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.

Side effects data

From 2011 Phase 3 trial • 404 Patients • NCT01226459
7%
Weight Increased
6%
Nasopharyngitis
4%
Upper Respiratory Tract Infection
4%
Headache
2%
Hypertension
2%
Sinusitis
1%
Asthenia
1%
Back Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Foam
Minoxidil Foam

Trial Design

1Treatment groups
Experimental Treatment
Group I: MicroneedlingExperimental Treatment1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vancouver General HospitalLead Sponsor
40 Previous Clinical Trials
19,595 Total Patients Enrolled
Jerry Shapiro, MBBSPrincipal InvestigatorUniversity of British Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025