- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375141
Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.
June 4, 2007 updated by: Bispebjerg Hospital
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, NV
- Bispebjerg Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merete Hædersdal, Bispebjerg Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
September 11, 2006
First Submitted That Met QC Criteria
September 11, 2006
First Posted (Estimate)
September 12, 2006
Study Record Updates
Last Update Posted (Estimate)
June 6, 2007
Last Update Submitted That Met QC Criteria
June 4, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- KF-01-316279
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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