HirsutismPhase 2/3NCT01461694
Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser
A Phase 2/3 study testing Intense Pulsed Light (IPL) and Alexandrite Laser in people with Hirsutism, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hirsutism
- What is being tested?
- Intense Pulsed Light (IPL) and Alexandrite Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Mar 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female Patients
- Minimum age 16years old
- Fitzpatrick skin types I-III
- Significant facial hair.
Who cannot join
- 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
Show all 9Show fewer
- Current coldsore
- Previous facial hair removal with laser or IPL in past 12 months
- Sun tanned skin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
Official title: Comparison of Intense Pulsed Light System 650 Advance Hand-Piece and Alexandrite Laser for Female Facial Hair Reduction
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
Read the 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.
- Conditions
- Hirsutism
- Being tested
- Intense Pulsed Light (IPL), Alexandrite Laser
- Keywords
- Hirsutism, Laser, Hair Reduction, IPL, Intense Pulsed Light
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Pulsed Light (IPL)Device
Half Face Treated with IPL
Alexandrite LaserDevice
Half face treated with Alexandrite Laser
| Study group | Role | What they receive |
|---|---|---|
| IPL | Active comparator | Half face treated with IPL Receives: Device: Intense Pulsed Light (IPL) |
| Alexandrite Laser | Active comparator | Half face treated with Alexandrite Laser Receives: Device: Alexandrite Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 3months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Gilmour, NHS Greater Glasgow and Clyde
- Investigators
- Adam Gilmour, MBChB, MRCS (Ed), Principal investigator, NHS Greater Glasgow and ClydeIain Mackay, MBChb, MRCS, FRCS (plast), Study chair, NHS Greater Glasgow and ClydeVivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas), Study director, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461694
- Sponsor's protocol ID
- GN11SU380
- Status last verified
- May 2012
- First submitted
- 25 Oct 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intense Pulsed Light System 650 Advance Hand-Piece and Alexandrite Laser for Female Facial Hair Reduction
- ClinicalTrials.gov ID
- NCT01461694
- Acronym / sponsor ID
- GN11SU380
- Conditions
- Hirsutism
- Keywords
- Hirsutism, Laser, Hair Reduction, IPL, Intense Pulsed Light
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL | Active comparator | Device: Intense Pulsed Light (IPL)Half face treated with IPL |
| Alexandrite Laser | Active comparator | Device: Alexandrite LaserHalf face treated with Alexandrite Laser |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female Patients
- Minimum age 16years old
- Fitzpatrick skin types I-III
- Significant facial hair.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intense Pulsed Light (IPL)Half Face Treated with IPL | Device | IPL |
| Alexandrite LaserHalf face treated with Alexandrite Laser | Device | Alexandrite Laser |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Gilmour, MBChB, MRCS (Ed) principal investigator
NHS Greater Glasgow and Clyde
Iain Mackay, MBChb, MRCS, FRCS (plast) study chair
NHS Greater Glasgow and Clyde
Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas) study director
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intense Pulsed Light (IPL) and Alexandrite Laser in people with Hirsutism, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total Hair Count measurement at 1month post final treatment from baseline (time frame: Baseline and 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.