Clinical trial · Interventional
Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol
NCT01533376CI-TRIAL-00037739terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: • To assess the possible utility of topical timolol in the management of port-wine mark (PWM) in Sturge-Weber syndrome in children.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Port-wine Mark | — | UNRESOLVED | — |
| Sturge Weber Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preservative free artificial tear gel. | Drug | — | UNRESOLVED |
| Timolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Timolol
- description
- Participants in this group will receive topical timolol
- interventionNames
- Drug: Timolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants in this group will receive Preservative free artificial tear gel.
- interventionNames
- Drug: Preservative free artificial tear gel.
Primary outcomes (1)
- measure
- Appearance of Port-wine Mark at treatment site
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 10 Years
Show eligibility criteria text
Inclusion criteria: * Age from 2 years to 10 years * Port-Wine Mark * English fluent and literate substitute decision maker * Substitute decision maker vision sufficient to read informed consent document Exclusion criteria: * Active ocular infection (conjunctivitis, keratitis,) * History of systemic conditions including hypo/hypertension, hypoglycemia, bradycardia, asthma or any contraindication to beta blocker use * Unable to comply with required follow-up * Substitute decision maker not English fluent or not literate * Substitute decision maker unable to read consent document * Patient already using systemic beta-blocker or beta-agonist (Patients already using topical beta-blocker for glaucoma will not be excluded from study).
References
Publications (15)
- BACKGROUNDHennedige AA, Quaba AA, Al-Nakib K. Sturge-Weber syndrome and dermatomal facial port-wine stains: incidence, association with glaucoma, and pulsed tunable dye laser treatment effectiveness. Plast Reconstr Surg. 2008 Apr;121(4):1173-1180. doi: 10.1097/01.prs.0000304606.33897.71. PMID 18349634
- BACKGROUNDJia W, Sun V, Tran N, Choi B, Liu SW, Mihm MC Jr, Phung TL, Nelson JS. Long-term blood vessel removal with combined laser and topical rapamycin antiangiogenic therapy: implications for effective port wine stain treatment. Lasers Surg Med. 2010 Feb;42(2):105-12. doi: 10.1002/lsm.20890. PMID 20166161
- BACKGROUNDChiummariello S, Mezzana P, Fioramonti P, Onesti MG, Alfano C, Scuderi N. The use of laser and Varioscope in the management of hemangiomas and vascular malformations. Acta Chir Plast. 2006;48(1):20-5. PMID 16722347
- BACKGROUNDLi W, Yamada I, Masumoto K, Ueda Y, Hashimoto K. Photodynamic therapy with intradermal administration of 5-aminolevulinic acid for port-wine stains. J Dermatolog Treat. 2010 Jul;21(4):232-9. doi: 10.3109/09546630903159099. PMID 20509816
- BACKGROUNDKautz G, Kautz I, Segal J, Zehren S. Treatment of resistant port wine stains (PWS) with pulsed dye laser and non-contact vacuum: a pilot study. Lasers Med Sci. 2010 Jul;25(4):525-9. doi: 10.1007/s10103-009-0727-7. Epub 2009 Dec 15. PMID 20013138
- BACKGROUNDMaruani A. [Sturge-Weber syndrome]. Presse Med. 2010 Apr;39(4):482-6. doi: 10.1016/j.lpm.2009.07.030. Epub 2010 Mar 10. French. PMID 20219318
- BACKGROUNDOnesti MG, Fioramonti P, Carella S, Spinelli G, Scuderi N. Surgical and laser treatment of Sturge-Weber syndrome. Aesthetic Plast Surg. 2009 Jul;33(4):666-8. doi: 10.1007/s00266-009-9327-y. Epub 2009 Mar 19. PMID 19296147