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

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ClinicalTrials.gov Identifier: NCT01461694
Recruitment Status : Unknown
Verified May 2012 by Adam Gilmour, NHS Greater Glasgow and Clyde.
Recruitment status was:  Enrolling by invitation
First Posted : October 28, 2011
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Adam Gilmour, NHS Greater Glasgow and Clyde

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461694


Locations
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United Kingdom
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
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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
More Information
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Responsible Party: Adam Gilmour, Clinical Laser Research Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01461694    
Other Study ID Numbers: GN11SU380
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012
Keywords provided by Adam Gilmour, NHS Greater Glasgow and Clyde:
Hirsutism
Laser
Hair Reduction
IPL
Intense Pulsed Light
Additional relevant MeSH terms:
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Hirsutism
Hair Diseases
Skin Diseases
Virilism