Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
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Purpose
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.
| Condition | Intervention | Phase |
|---|---|---|
|
Infantile Hemangiomas |
Drug: Timolol 0.5% topical Drug: Mupirocin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas |
- Time to Wound Re-epithelization [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
- Reduction in Ulcer Surface Area and Depth [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
- Investigator's Global Evaluation of Disease [ Time Frame: At 3 months ] [ Designated as safety issue: No ]A scoring system developed to measure clinical improvement of ulcerated hemangioma.
- Timolol Serum Level [ Time Frame: Measured at 1 month into therapy ] [ Designated as safety issue: Yes ]
- Evaluate number of participants with changes in Glucose levels after drug is applied [ Time Frame: Baseline, day 7, day 14 ] [ Designated as safety issue: Yes ]
Glucose monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.
Glucose values < 60 mg/dL will be considered significant.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
- Evaluate number of participants with evidence of changes in blood pressure following administration of Timolol 0.5% GFS [ Time Frame: Baseline, day 7, day 14 ] [ Designated as safety issue: Yes ]
Blood pressure monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.
Blood pressure values < 3rd percentile (systolic or diastolic) will be considered significant for hypotension.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
- Pain scores (presence or absence) on the Wong-Baker faces scale [ Time Frame: Baseline, day 7, day 14, 1 month, 2 months ] [ Designated as safety issue: Yes ]
Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Pain will be assessed using the Wong-Baker faces scale.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
- Number of participants with presence or absence of Infection [ Time Frame: Baseline, day 7, day 14, 1 month, 2 months ] [ Designated as safety issue: Yes ]
Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of drainage or exudate, and/or culture positivity.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
- Number of participants with presence (or absence) of active bleeding [ Time Frame: Baseline, day 7, day 14, 1 month, 2 months ] [ Designated as safety issue: Yes ]
Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of active bleeding.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
- Evaluate number of participants with changes in Heart Rate after drug is applied [ Time Frame: Baseline, day 7, day 14 ] [ Designated as safety issue: Yes ]
Glucose and vital sign monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.
Heart rate values < 3rd percentile will be considered significant and indicative of bradycardia.
Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Timolol 0.5% Gel Forming Solution (GFS)
Half of enrolled subjects will receive topical Timolol
|
Drug: Timolol 0.5% topical
Dose-based escalation schedule for topical application: 4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day 8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day Other Name: Timolol 0.5% Gel Forming Solution
|
|
Active Comparator: Mupirocin 2% ointment
Half of enrolled subjects will receive Mupirocin
|
Drug: Mupirocin
Topical application twice per day for 60 days
|
Detailed Description:
Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.
In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.
The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.
In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.
Eligibility| Ages Eligible for Study: | 1 Month to 8 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants weighing between 4-12kg
- Infants with corrected gestational age 44 weeks - 8 months of age
- Infant with an ulcerated hemangioma
- Informed consent
Exclusion Criteria:
- Ulceration larger than 16cm2
- Ulcerated hemangioma with active bleeding or infection at time of enrollment
- Disease threatening hemangioma meeting criteria for oral propranolol
- Previous treatment with topical/oral corticosteroid or propranolol
- Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder
- History of an allergic reaction to Mupirocin or Timolol
- Currently taking medication that would interact with beta-blockers
Contacts and Locations| Contact: Albert C. Yan, MD | 215-590-2169 | yana@email.chop.edu |
| Contact: Patrick McMahon, MD | 215-590-2169 | mcmahon@email.chop.edu |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Albert C. Yan, MD | Children's Hospital of Philadelphia, Chair of Pediatric Dermatology |
| Principal Investigator: | Vikash S. Oza, MD | Children's Hospital of Philadelphia, Attending Physician |
| Principal Investigator: | Patrick McMahon, MD | Children's Hospital of Philadelphia |
More Information
Publications:
| Responsible Party: | Albert Yan, Chief, Section of Pediatric Dermatology, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01408056 History of Changes |
| Other Study ID Numbers: | 10-007923 |
| Study First Received: | March 10, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Philadelphia:
|
Hemangioma Infantile Hemangioma Ulcerated Hemangioma |
Timolol Beta blocker Vascular anomaly |
Additional relevant MeSH terms:
|
Hemangioma Ulcer Hemangioma, Capillary Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Pathologic Processes Timolol Mupirocin Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Protein Synthesis Inhibitors Enzyme Inhibitors Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013