A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on
The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type
| Condition(s) | Hemangioma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. T |
| Who can participate | Inclusion Criteria: 1. Subjects aged less than 3 months, male or female. 2. Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase. 3. Absence or minimal appearance of the lesion at birth 4. More pronounced appearance within 1 month of birth. 5. Willingness of parent/guardian to participate in the study 6. Willingness of parent/guardian to receive EXPERIMENTAL treatment 7. Informed consent agreement signed by the parent/guardian 8. Willingness of parent/guardian to follow the treatment schedule and post treatment care requirements 9. Willingness of parent/guardian to not use topical or systemic (oral) TREATMENT medications of the hemangioma other than those prescribed by the investigators during the study period. Exclusion Cri |
| Ages | 3 Months |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Massachusetts General Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2011-02 |
| NCT ID | NCT01873131 |
| Official listing | https://clinicaltrials.gov/study/NCT01873131 |