HealthyNCT01763723
Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects
A study testing IPL-home use device in people with Healthy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device. 21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IPL-home use device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Oct 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV
Who cannot join
- disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
Trial locations and contacts
1 site in 1 country.
About this study
This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device.
21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.
Read the detailed description
Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.
- Conditions
- Healthy
- Being tested
- IPL-home use device
- Keywords
- Intense pulsed light,, UV-exposure,, skin type,, safety,, pigment,, home-use, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL-home use deviceDevice
A light based home use device for hair removal
| Study group | Role | What they receive |
|---|---|---|
| IPL after UV-exposure | Experimental | 8 UV-exposures followed by 3 weekly IPL exposures Receives: Device: IPL-home use device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin reaction development
Redness, edema, pigment changes, texture changes, blisters and crusting
Measured: Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure
Secondary outcomes (1)
Pain
Measured: Immediately after IPL exposure (approx. 2 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Haak, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763723
- Sponsor's protocol ID
- H-1-2012-025
- Status last verified
- Jul 2015
- First submitted
- 20 Dec 2012
- Last updated
- 31 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects
- ClinicalTrials.gov ID
- NCT01763723
- Acronym / sponsor ID
- H-1-2012-025
- Conditions
- Healthy
- Keywords
- Intense pulsed light,, UV-exposure,, skin type,, safety,, pigment,, home-use, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Jan 2013 (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.
This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device.
21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.
Detailed description
Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPL after UV-exposure | Experimental | Device: IPL-home use device8 UV-exposures followed by 3 weekly IPL exposures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV
Key exclusion criteria (1 listed)
- disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
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 |
|---|---|---|
| IPL-home use deviceA light based home use device for hair removal | Device | IPL after UV-exposure |
Primary outcome
Changes in skin reaction development
Time frame: Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure
Redness, edema, pigment changes, texture changes, blisters and crusting
1 secondary outcome
Pain
Time frame: Immediately after IPL exposure (approx. 2 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL-home use device in people with Healthy, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2015. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in skin reaction development (time frame: Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure). 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 31 Jul 2015.