NCT01461694

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

October 25, 2011

Last Update Submit

May 11, 2012

Conditions

Keywords

HirsutismLaserHair ReductionIPLIntense Pulsed Light

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

IPL

ACTIVE COMPARATOR

Half face treated with IPL

Device: Intense Pulsed Light (IPL)

Alexandrite Laser

ACTIVE COMPARATOR

Half face treated with Alexandrite Laser

Device: Alexandrite Laser

Interventions

Half Face Treated with IPL

IPL

Half face treated with Alexandrite Laser

Alexandrite Laser

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female Patients
  • Minimum age 16years old
  • Fitzpatrick skin types I-III
  • Significant facial hair.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Hirsutism

Interventions

Intense Pulsed Light TherapyLasers, Solid-State

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhototherapyTherapeuticsLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Adam Gilmour, MBChB, MRCS (Ed)

    NHS Greater Glasgow & Clyde

    PRINCIPAL INVESTIGATOR
  • Iain Mackay, MBChb, MRCS, FRCS (plast)

    NHS Greater Glasgow & Clyde

    STUDY CHAIR
  • Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas)

    NHS Greater Glasgow & Clyde

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Laser Research Fellow

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 28, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations