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Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT02154503
Recruitment Status : Unknown
Verified May 2014 by Jerry Shapiro, Vancouver General Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jerry Shapiro, Vancouver General Hospital

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: topical 5% Minoxidil (Microneedling) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia- Pilot Study
Study Start Date : April 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

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)



Primary Outcome Measures :
  1. Hair caliber diameter and hair counts will be measured on both the treated and untreated sides. [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Adverse effects of the procedure will be recorded. [ Time Frame: three months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154503


Contacts
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Contact: Jerry Shapiro, MD 6048755151 jerry.shapiro@vch.ca
Contact: Llorenia Muir-Green, MBBS 6048755151 Llorenia.MuirGreen@vch.ca

Locations
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Canada, British Columbia
The Skin Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Principal Investigator: Jerry Shapiro, MD FRCPC         
Sponsors and Collaborators
Vancouver General Hospital
Investigators
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Principal Investigator: Jerry Shapiro, MBBS University of British Columbia

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Responsible Party: Jerry Shapiro, Clinical Professor, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT02154503     History of Changes
Other Study ID Numbers: H13-03501
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents