Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

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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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Adverse effects of the procedure will be recorded.

Condition

Androgenetic Alopecia

Intervention

topical 5% Minoxidil (Microneedling)

Study Arms / Comparison Groups

 Microneedling
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

April 2014

Completion Date

March 2017

Primary Completion Date

March 2017

Eligibility Criteria

        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.
      

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jerry Shapiro, MBBS, 6048755151, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02154503

Organization ID

H13-03501


Responsible Party

Principal Investigator

Study Sponsor

Vancouver General Hospital


Study Sponsor

Jerry Shapiro, MBBS, Principal Investigator, University of British Columbia


Verification Date

May 2014