Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02154503
• Other study ID #: H13-03501
• Status: Recruiting
• Phase: Phase 1
• First received: May 30, 2014
• Last updated: June 2, 2014
• Start date: April 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2014
• Source: Vancouver General Hospital
• Contact: Jerry Shapiro, MD
• Phone: 6048755151
• Email: jerry.shapiro[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• topical 5% Minoxidil (Microneedling)

Locations

Country	Name	City	State
Canada	The Skin Care Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.		three months	No
Secondary	Adverse effects of the procedure will be recorded.		three months	No