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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- Hair caliber diameter and hair counts will be measured on both the treated and untreated sides. [ Time Frame: three months ]
- Adverse effects of the procedure will be recorded. [ Time Frame: three months ]
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
|Contact: Jerry Shapiro, MDfirstname.lastname@example.org|
|Contact: Llorenia Muir-Green, MBBS||6048755151||Llorenia.MuirGreen@vch.ca|
|Canada, British Columbia|
|The Skin Care Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E8|
|Principal Investigator: Jerry Shapiro, MD FRCPC|
|Principal Investigator:||Jerry Shapiro, MBBS||University of British Columbia|