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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Adam Gilmour, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01461694
First received: October 25, 2011
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Hirsutism
Device: Intense Pulsed Light (IPL)
Device: Alexandrite Laser
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Change in total Hair Count measurement at 1month post final treatment from baseline [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3months post final treatment ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461694

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Adam Gilmour, Clinical Laser Research Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01461694     History of Changes
Other Study ID Numbers: GN11SU380
Study First Received: October 25, 2011
Last Updated: May 11, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Hirsutism
Laser
Hair Reduction
IPL
Intense Pulsed Light

Additional relevant MeSH terms:
Hirsutism
Hypertrichosis
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014