Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser

NCT ID: NCT01461694

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece with the alexandrite laser for the purposes of female facial hair reduction

Detailed Description

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This is a randomised (splitface)controlled trial, comparing the use of the Intense Pulsed Light (IPL) system 650 advance handpiece against the Alexandrite Laser for the purposes of female facial hair reduction. Previous studies have shown that the alexandrite laser is superior to IPL in achieving hair reduction. A new handpiece (Lynton, Lumina 650 advance) available for the IPL system is designed to further optimise its use in removing female facial hair (particularly those hair colours previously unresponsive to treatment). This study will compare the alexandrite laser to the IPL system using the new handpiece. This may lead to improvements in the treatment of female patients with male pattern facial hair. Female patients referred to our facial hair reduction service will be recruited to this study. 1/2 their face will be treated with IPL and 1/2 with alexandrite laser. Each participant will receive 6 full treatments at approximately 6 weekly intervals. Participants will be asked to fill in a satisfaction questionnaire and have clinical photographs taken pre treatment and at 1 and 3months post final treatment. All treatments will be carried out in our dedicated laser suite at Glasgow Royal Infirmary.

Conditions

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Hirsutism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IPL

Half face treated with IPL

Group Type ACTIVE_COMPARATOR

Intense Pulsed Light (IPL)

Intervention Type DEVICE

Half Face Treated with IPL

Alexandrite Laser

Half face treated with Alexandrite Laser

Group Type ACTIVE_COMPARATOR

Alexandrite Laser

Intervention Type DEVICE

Half face treated with Alexandrite Laser

Interventions

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Intense Pulsed Light (IPL)

Half Face Treated with IPL

Intervention Type DEVICE

Alexandrite Laser

Half face treated with Alexandrite Laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female Patients
* Minimum age 16years old
* Fitzpatrick skin types I-III
* Significant facial hair.

Exclusion Criteria

* Fitzpatrick skin types IV-VI
* Age less than 16years old
* Males
* No visible facial hair growth
* Use of electrolysis or depilatory creams 6weeks prior to treatment
* Active acnes
* Current coldsore
* Previous facial hair removal with laser or IPL in past 12 months
* Sun tanned skin
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Adam Gilmour

Clinical Laser Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Gilmour, MBChB, MRCS (Ed)

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow & Clyde

Iain Mackay, MBChb, MRCS, FRCS (plast)

Role: STUDY_CHAIR

NHS Greater Glasgow & Clyde

Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas)

Role: STUDY_DIRECTOR

NHS Greater Glasgow & Clyde

Locations

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Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GN11SU380

Identifier Type: -

Identifier Source: org_study_id

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