Photodamaged SkinNCT00375141
Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.
A study testing Pulsed dye laser, Intense pulsed light in people with Photodamaged Skin, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the trial is to compare clinical efficacy and occurrence of side effects in the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Pulsed dye laser, Intense pulsed light
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento May 2007
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild to moderate bilateral facial photodamage
- Symmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
- Fitzpatrick's skin type of Type I, II, or III, without significant tan
- Age > 40 years
- Able to read and comprehend Danish
- Informed consent agreement signed by the subject
- Willingness to follow the treatment schedule and posttreatment follow-up evaluations
- Willingness to allow photographs of the treated area to be taken for evaluation of efficacy.
Who cannot join
- Scarring or infection of the area to be treated
- Known photosensitivity
- Presence of a suntan in the area to be treated
- Subjects taken medication known to induce photosensitivity in the previous three months
- Known anticoagulation or thromboembolic conditions
- Subjects taking anticoagulation medication
Show all 13Show fewer
- Subjects taking Accutane within the past 6 months
- Subjects treated with aspirins or anti-inflammatory drugs
- Subjects who are immunocompromised or have a medical history that is inappropriate for the study per the investigator's clinical judgment.
- Dermabrasion, chemical peel, laser or IPL treatment, or collagen injection therapy in the facial area in the past 12 months.
- Previous formation of hypertrophic scars or keloids
- Subjects who are pregnant or lactating
- Asymmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the trial is to compare clinical efficacy and occurrence of side effects in the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.
- Conditions
- Photodamaged Skin
- Being tested
- Pulsed dye laser, Intense pulsed light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laser, Intense pulsed lightDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study completionMay 2007
Why it stopped: Inclusion, treatments and follow-up are finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Merete Hædersdal, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375141
- Sponsor's protocol ID
- KF-01-316279
- Status last verified
- Jun 2007
- First submitted
- 11 Sep 2006
- Last updated
- 6 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.
- ClinicalTrials.gov ID
- NCT00375141
- Acronym / sponsor ID
- KF-01-316279
- Conditions
- Photodamaged Skin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion, treatments and follow-up are finished
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2006 (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 the trial is to compare clinical efficacy and occurrence of side effects in the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mild to moderate bilateral facial photodamage
- Symmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
- Fitzpatrick's skin type of Type I, II, or III, without significant tan
- Age > 40 years
- Able to read and comprehend Danish
Key exclusion criteria (13 listed)
- Scarring or infection of the area to be treated
- Known photosensitivity
- Presence of a suntan in the area to be treated
- Subjects taken medication known to induce photosensitivity in the previous three months
- Known anticoagulation or thromboembolic conditions
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 |
|---|---|---|
| Pulsed dye laser, Intense pulsed light | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Inclusion, treatments and follow-up are finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2007.
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
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Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Not yet recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Photodamaged Skin, Skin Cancer Prevention
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
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.
Merete Hædersdal principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser, Intense pulsed light in people with Photodamaged Skin, 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Jun 2007. 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 was stopped early (reason given: Inclusion, treatments and follow-up are finished). 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.
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 6 Jun 2007.