Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

NCT ID: NCT02154503

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

topical 5% Minoxidil (Microneedling)

Intervention Type: DEVICE

Interventions

topical 5% Minoxidil (Microneedling)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vancouver General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jerry Shapiro

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry Shapiro, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

The Skin Care Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jerry Shapiro, MD

Role: CONTACT

jerry.shapiro@vch.ca

6048755151

Llorenia Muir-Green, MBBS

Role: CONTACT

Llorenia.MuirGreen@vch.ca

6048755151

Other Identifiers

H13-03501

Identifier Type: -

Identifier Source: org_study_id