Infantile HemangiomasPhase 2TOUCHNCT01408056
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
A Phase 2 study testing Timolol 0.5% Gel Forming Solution (GFS) and Mupirocin 2% Ointment in people with Infantile Hemangiomas, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 8 months
- Conditions the study is for
- Infantile Hemangiomas
- What is being tested?
- Timolol 0.5% Gel Forming Solution (GFS) and Mupirocin 2% Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants weighing between 4-12kg
- Infants with corrected gestational age 44 weeks - 8 months of age
- Infant with an ulcerated hemangioma
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas
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.
Read the 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.
- Conditions
- Infantile Hemangiomas
- Being tested
- Timolol 0.5% Gel Forming Solution (GFS), Mupirocin 2% Ointment
- Keywords
- Hemangioma, Infantile Hemangioma, Ulcerated Hemangioma, Timolol, Beta blocker, Vascular anomaly
- Medical subject headings
- Hemangioma, Hemangioma, Capillary, Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol 0.5% Gel Forming Solution (GFS)Drug
Also called 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
Mupirocin 2% OintmentDrug
Also called Mupirocin
Topical application twice per day for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Timolol 0.5% Gel Forming Solution (GFS) | Experimental | Half of enrolled subjects will receive topical Timolol Receives: Drug: Timolol 0.5% Gel Forming Solution (GFS) |
| Mupirocin 2% ointment | Active comparator | Half of enrolled subjects will receive Mupirocin Receives: Drug: Mupirocin 2% Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Wound Re-epithelization
Measured: At 3 months
Secondary outcomes (9)
Reduction in Ulcer Surface Area and Depth
Measured: At 3 months
Investigator's Global Evaluation of Disease
A scoring system developed to measure clinical improvement of ulcerated hemangioma.
Measured: At 3 months
Timolol Serum Level
Measured: Measured at 1 month into therapy
Evaluate number of participants with changes in Glucose levels after drug is applied
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.
Measured: Baseline, day 7, day 14
Evaluate number of participants with evidence of changes in blood pressure following administration of Timolol 0.5% GFS
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.
Measured: Baseline, day 7, day 14
Pain scores (presence or absence) on the Wong-Baker faces scale
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.
Measured: Baseline, day 7, day 14, 1 month, 2 months
Number of participants with presence or absence of Infection
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.
Measured: Baseline, day 7, day 14, 1 month, 2 months
Number of participants with presence (or absence) of active bleeding
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.
Measured: Baseline, day 7, day 14, 1 month, 2 months
Evaluate number of participants with changes in Heart Rate after drug is applied
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.
Measured: Baseline, day 7, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infantile HemangiomasStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Responsible party
- Principal investigator, Albert Yan, Children's Hospital of Philadelphia
- Investigators
- Albert C. Yan, MD, Principal investigator, Children's Hospital of Philadelphia, Chair of Pediatric DermatologyVikash S. Oza, MD, Principal investigator, Children's Hospital of Philadelphia, Attending PhysicianPatrick McMahon, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408056
- Sponsor's protocol ID
- 10-007923
- Acronym
- TOUCH
- Status last verified
- Jan 2014
- First submitted
- 10 Mar 2011
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pope E, Chakkittakandiyil A. Topical timolol gel for infantile hemangiomas: a pilot study. Arch Dermatol. 2010 May;146(5):564-5. doi: 10.1001/archdermatol.2010.67. No abstract available.
PubMed 20479314Sivamani RK, Pullar CE, Manabat-Hidalgo CG, Rocke DM, Carlsen RC, Greenhalgh DG, Isseroff RR. Stress-mediated increases in systemic and local epinephrine impair skin wound healing: potential new indication for beta blockers. PLoS Med. 2009 Jan 13;6(1):e12. doi: 10.1371/journal.pmed.1000012.
PubMed 19143471Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
PubMed 19706583Khunger N, Pahwa M. Dramatic response to topical timolol lotion of a large hemifacial infantile haemangioma associated with PHACE syndrome. Br J Dermatol. 2011 Apr;164(4):886-8. doi: 10.1111/j.1365-2133.2010.10177.x. No abstract available.
PubMed 21158749Chamlin SL, Haggstrom AN, Drolet BA, Baselga E, Frieden IJ, Garzon MC, Horii KA, Lucky AW, Metry DW, Newell B, Nopper AJ, Mancini AJ. Multicenter prospective study of ulcerated hemangiomas. J Pediatr. 2007 Dec;151(6):684-9, 689.e1. doi: 10.1016/j.jpeds.2007.04.055. Epub 2007 Aug 24.
PubMed 18035154
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas
- ClinicalTrials.gov ID
- NCT01408056
- Acronym / sponsor ID
- TOUCH / 10-007923
- Conditions
- Infantile Hemangiomas
- Keywords
- Hemangioma, Infantile Hemangioma, Ulcerated Hemangioma, Timolol, Beta blocker, Vascular anomaly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol 0.5% Gel Forming Solution (GFS) | Experimental | Drug: Timolol 0.5% Gel Forming Solution (GFS)Half of enrolled subjects will receive topical Timolol |
| Mupirocin 2% ointment | Active comparator | Drug: Mupirocin 2% OintmentHalf of enrolled subjects will receive Mupirocin |
Who may qualify
- Ages
- 1 month to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants weighing between 4-12kg
- Infants with corrected gestational age 44 weeks - 8 months of age
- Infant with an ulcerated hemangioma
- Informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol 0.5% Gel Forming Solution (GFS)Also: Timolol 0.5% topicalDose-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 | Drug | Timolol 0.5% Gel Forming Solution (GFS) |
| Mupirocin 2% OintmentAlso: MupirocinTopical application twice per day for 60 days | Drug | Mupirocin 2% ointment |
Primary outcome
Time to Wound Re-epithelization
Time frame: At 3 months
9 secondary outcomes
Reduction in Ulcer Surface Area and Depth
Time frame: At 3 months
Investigator's Global Evaluation of Disease
Time frame: At 3 months
Timolol Serum Level
Time frame: Measured at 1 month into therapy
Evaluate number of participants with changes in Glucose levels after drug is applied
Time frame: Baseline, day 7, day 14
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
Pain scores (presence or absence) on the Wong-Baker faces scale
Time frame: Baseline, day 7, day 14, 1 month, 2 months
Number of participants with presence or absence of Infection
Time frame: Baseline, day 7, day 14, 1 month, 2 months
Number of participants with presence (or absence) of active bleeding
Time frame: Baseline, day 7, day 14, 1 month, 2 months
Evaluate number of participants with changes in Heart Rate after drug is applied
Time frame: Baseline, day 7, day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Background: PubMed 20479314Pope E, Chakkittakandiyil A. Topical timolol gel for infantile hemangiomas: a pilot study. Arch Dermatol. 2010 May;146(5):564-5. doi: 10.1001/archdermatol.2010.67. No abstract available.
- Background: PubMed 19143471Sivamani RK, Pullar CE, Manabat-Hidalgo CG, Rocke DM, Carlsen RC, Greenhalgh DG, Isseroff RR. Stress-mediated increases in systemic and local epinephrine impair skin wound healing: potential new indication for beta blockers. PLoS Med. 2009 Jan 13;6(1):e12. doi: 10.1371/journal.pmed.1000012.
- Background: PubMed 19706583Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
- Background: PubMed 21158749Khunger N, Pahwa M. Dramatic response to topical timolol lotion of a large hemifacial infantile haemangioma associated with PHACE syndrome. Br J Dermatol. 2011 Apr;164(4):886-8. doi: 10.1111/j.1365-2133.2010.10177.x. No abstract available.
- Background: PubMed 18035154Chamlin SL, Haggstrom AN, Drolet BA, Baselga E, Frieden IJ, Garzon MC, Horii KA, Lucky AW, Metry DW, Newell B, Nopper AJ, Mancini AJ. Multicenter prospective study of ulcerated hemangiomas. J Pediatr. 2007 Dec;151(6):684-9, 689.e1. doi: 10.1016/j.jpeds.2007.04.055. Epub 2007 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert C. Yan, MD principal investigator
Children's Hospital of Philadelphia, Chair of Pediatric Dermatology
Vikash S. Oza, MD principal investigator
Children's Hospital of Philadelphia, Attending Physician
Patrick McMahon, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timolol 0.5% Gel Forming Solution (GFS) and Mupirocin 2% Ointment in people with Infantile Hemangiomas, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Wound Re-epithelization (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01408056, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.