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

Primary Purpose

Hirsutism

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Intense Pulsed Light (IPL)
Alexandrite Laser
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hirsutism focused on measuring Hirsutism, Laser, Hair Reduction, IPL, Intense Pulsed Light

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IPL

Alexandrite Laser

Arm Description

Half face treated with IPL

Half face treated with Alexandrite Laser

Outcomes

Primary Outcome Measures

Change in total Hair Count measurement at 1month post final treatment from baseline
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
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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2011
Last Updated
May 11, 2012
Sponsor
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT01461694
Brief Title
Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser
Official Title
Comparison of Intense Pulsed Light System 650 Advance Hand-Piece and Alexandrite Laser for Female Facial Hair Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsutism
Keywords
Hirsutism, Laser, Hair Reduction, IPL, Intense Pulsed Light

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPL
Arm Type
Active Comparator
Arm Description
Half face treated with IPL
Arm Title
Alexandrite Laser
Arm Type
Active Comparator
Arm Description
Half face treated with Alexandrite Laser
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light (IPL)
Intervention Description
Half Face Treated with IPL
Intervention Type
Device
Intervention Name(s)
Alexandrite Laser
Intervention Description
Half face treated with Alexandrite Laser
Primary Outcome Measure Information:
Title
Change in total Hair Count measurement at 1month post final treatment from baseline
Description
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
Time Frame
Baseline and 1 month
Title
Change in total hair count at 3months post final treatment from baseline
Description
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
Time Frame
Baseline and 3months post final treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Gilmour, MBChB, MRCS (Ed)
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iain Mackay, MBChb, MRCS, FRCS (plast)
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas)
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Study Director
Facility Information:
Facility Name
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom

12. IPD Sharing Statement

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

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