Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

NCT02154503 | Unknown Phase 1 DMC

• 1 other identifier: H13-03501
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

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

  three months

Secondary Outcomes (1)

• Adverse effects of the procedure will be recorded.

  three months

Study Arms (1)

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.

Device: topical 5% Minoxidil (Microneedling)

Interventions

topical 5% Minoxidil (Microneedling) DEVICE

Microneedling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men between the ages 18-65.
• Disease Stage: Norwood Hamilton IIIa-IV.
• Length of time with disease \< 10 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver General Hospital: lead

Study Sites (1)

The Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Jerry Shapiro, MBBS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerry Shapiro, MD

CONTACT

6048755151; jerry.shapiro@vch.ca

Llorenia Muir-Green, MBBS

CONTACT

6048755151; Llorenia.MuirGreen@vch.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

CA (1)