Androgenetic AlopeciaPhase 1NCT02154503
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia
A Phase 1 study testing topical 5% Minoxidil (Microneedling) in people with Androgenetic Alopecia, run by Vancouver General Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- topical 5% Minoxidil (Microneedling)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men between the ages 18-65.
- Disease Stage: Norwood Hamilton IIIa-IV.
- Length of time with disease < 10 years.
Who cannot join
- Must not have other concurrent hair disease.
- 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.
- Patients under the age of 18.
- Patients who are unable to offer consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Jerry Shapiro, MD FRCPC
About this study
Official title: 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- topical 5% Minoxidil (Microneedling)
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical 5% Minoxidil (Microneedling)Device
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | 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. Receives: Device: topical 5% Minoxidil (Microneedling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.
Measured: three months
Secondary outcomes (1)
Adverse effects of the procedure will be recorded.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerry Shapiro, Vancouver General Hospital
- Investigators
- Jerry Shapiro, MBBS, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154503
- Sponsor's protocol ID
- H13-03501
- Status last verified
- May 2014
- First submitted
- 30 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia- Pilot Study
- ClinicalTrials.gov ID
- NCT02154503
- Acronym / sponsor ID
- H13-03501
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: topical 5% Minoxidil (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men between the ages 18-65.
- Disease Stage: Norwood Hamilton IIIa-IV.
- Length of time with disease < 10 years.
Key exclusion criteria (4 listed)
- Must not have other concurrent hair disease.
- 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.
- Patients under the age of 18.
- Patients who are unable to offer consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical 5% Minoxidil (Microneedling) | Device | Microneedling |
Primary outcome
Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.
Time frame: three months
1 secondary outcome
Adverse effects of the procedure will be recorded.
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Shapiro, MBBS principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topical 5% Minoxidil (Microneedling) in people with Androgenetic Alopecia, run by Vancouver General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerry Shapiro, MD (6048755151, jerry.shapiro@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair caliber diameter and hair counts will be measured on both the treated and untreated sides. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.