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Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.

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ClinicalTrials.gov Identifier: NCT00375141
Recruitment Status : Terminated (Inclusion, treatments and follow-up are finished)
First Posted : September 12, 2006
Last Update Posted : June 6, 2007
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Photodamaged Skin Device: Pulsed dye laser, Intense pulsed light

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Study Completion Date : May 2007
Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375141


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, NV
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Merete Hædersdal Bispebjerg Hospital
More Information

ClinicalTrials.gov Identifier: NCT00375141     History of Changes
Other Study ID Numbers: KF-01-316279
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: June 6, 2007
Last Verified: June 2007