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NCT00375141 Clinical Trial

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

Photodamaged Skin Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00375141
Other study ID # KF-01-316279
Secondary ID
Status Terminated
Phase N/A
First received September 11, 2006
Last updated June 4, 2007
Est. completion date May 2007

Study information
Verified date June 2007
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Device:
• Pulsed dye laser, Intense pulsed light

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

See also
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