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

Sponsor

NHS Greater Glasgow and Clyde (Other)

Overall Status

Unknown status

CT.gov ID

NCT01461694

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hirsutism	Device: Intense Pulsed Light (IPL) Device: Alexandrite Laser	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Intense Pulsed Light System 650 Advance Hand-Piece and Alexandrite Laser for Female Facial Hair Reduction

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IPL Half face treated with IPL	Device: Intense Pulsed Light (IPL) Half Face Treated with IPL
Active Comparator: Alexandrite Laser Half face treated with Alexandrite Laser	Device: Alexandrite Laser Half face treated with Alexandrite Laser

Arm

Intervention/Treatment

Active Comparator: IPL

Half face treated with IPL

Device: Intense Pulsed Light (IPL)

Half Face Treated with IPL

Active Comparator: Alexandrite Laser

Half face treated with Alexandrite Laser

Device: Alexandrite Laser

Half face treated with Alexandrite Laser

Outcome Measures

Primary Outcome Measures

Change in total Hair Count measurement at 1month post final treatment from baseline [Baseline and 1 month]
Pre Treatment hair count assessed using videomicroscopy as baseline. Post final treatment hair counts will be measured again at 1month to assess if there has been a reduction in total hair count from pre-treatment
Change in total hair count at 3months post final treatment from baseline [Baseline and 3months post final treatment]
Pre Treatment hair count assessed using videomicroscopy as baseline. Post final treatment hair counts will be measured again at 3months to assess if there has been a reduction in total hair count from pre-treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary	Glasgow		United Kingdom	G4 0SF

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Investigators

Principal Investigator: Adam Gilmour, MBChB, MRCS (Ed), NHS Greater Glasgow & Clyde
Study Chair: Iain Mackay, MBChb, MRCS, FRCS (plast), NHS Greater Glasgow & Clyde
Study Director: Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas), NHS Greater Glasgow & Clyde