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

May 11, 2012 updated by: Adam Gilmour, NHS Greater Glasgow and Clyde

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total Hair Count measurement at 1month post final treatment from baseline
Time Frame: 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
Baseline and 1 month
Change in total hair count at 3months post final treatment from baseline
Time Frame: 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
Baseline and 3months post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 14, 2012

Last Update Submitted That Met QC Criteria

May 11, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN11SU380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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