NCT00375141

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 6, 2007

Status Verified

June 1, 2007

First QC Date

September 11, 2006

Last Update Submit

June 4, 2007

Conditions

Photodamaged Skin

Interventions

Pulsed dye laser, Intense pulsed lightDEVICE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, Denmark

Location

MeSH Terms

Interventions

Lasers, Dye

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Merete Hædersdal

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Completion

May 1, 2007

Last Updated

June 6, 2007

Record last verified: 2007-06

Locations

DK(1)