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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00375141
Collaborator
(none)
1
Location

Study Details

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 Phase
  • Device: Pulsed dye laser, Intense pulsed light
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital Copenhagen Denmark NV

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Principal Investigator: Merete Hædersdal, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00375141
    Other Study ID Numbers:
    • KF-01-316279
    First Posted:
    Sep 12, 2006
    Last Update Posted:
    Jun 6, 2007
    Last Verified:
    Jun 1, 2007

    Study Results

    No Results Posted as of Jun 6, 2007