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

This study has been terminated.
(Inclusion, treatments and follow-up are finished)
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00375141
First received: September 11, 2006
Last updated: June 4, 2007
Last verified: June 2007
  Purpose

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 Intervention
Photodamaged Skin
Device: Pulsed dye laser, Intense pulsed light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind

Further study details as provided by Bispebjerg Hospital:

Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375141

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

No publications provided

ClinicalTrials.gov Identifier: NCT00375141     History of Changes
Other Study ID Numbers: KF-01-316279
Study First Received: September 11, 2006
Last Updated: June 4, 2007
Health Authority: Denmark: Ministry of Health

ClinicalTrials.gov processed this record on November 24, 2014