Clinical trial NCT01461694: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hirsutism
Keywords: Hirsutism
Laser
Hair Reduction
IPL
Intense Pulsed Light
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in total Hair Count measurement at 1month post final treatment from baseline
timeFrame: Baseline and 1 month
measure: Change in total hair count at 3months post final treatment from baseline
timeFrame: Baseline and 3months post final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Adam Gilmour, MBChB, MRCS (Ed)
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow & Clyde
name: Iain Mackay, MBChb, MRCS, FRCS (plast)
role: STUDY_CHAIR
affiliation: NHS Greater Glasgow & Clyde
name: Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas)
role: STUDY_DIRECTOR
References: