Port-Wine Stain Clinical Trial
| Verified date | June 2008 |
| Source | Bispebjerg Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ministry of Health |
| Study type | Interventional |
The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III. Exclusion Criteria: - Patients below two years of age. - Pregnant or breastfeeding patients. - Patients with known increased sensitivity to visible light. - Patients with a tendency to produce hypertrophic scars or celoids. - Patients with skin types IV, V and VI. - Patients who are clearly pigmented following recent exposure to the sun or a solarium. - Patients treated with Roaccutane during the last six months. - Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Bispebjerg Hospital | Copenhagen | Copenhagen nv |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital |
Denmark,
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