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

Hirsutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01461694
• Other study ID #: GN11SU380
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: October 25, 2011
• Last updated: May 11, 2012
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirsutism

Intervention

Device:
• Intense Pulsed Light (IPL)
Half Face Treated with IPL
• Alexandrite Laser
Half face treated with Alexandrite Laser

Locations

Country	Name	City	State
United Kingdom	Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 1 month	No
Primary	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	Baseline and 3months post final treatment	No