Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia- Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: topical 5% Minoxidil (Microneedling)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jerry Shapiro, MD; Phone Number: 6048755151; Email: jerry.shapiro@vch.ca
• Study Contact Backup: Name: Llorenia Muir-Green, MBBS; Phone Number: 6048755151; Email: Llorenia.MuirGreen@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Recruiting
      • The Skin Care Centre
      • Principal Investigator: Jerry Shapiro, MD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Microneedling; 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.

Device: topical 5% Minoxidil (Microneedling)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.	three months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effects of the procedure will be recorded.	three months

Collaborators and Investigators

• Sponsor: Vancouver General Hospital
• Investigators: Principal Investigator: Jerry Shapiro, MBBS, University of British Columbia

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: June 2, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: H13-03501