HemangiomaEarly Phase 1NCT01147601
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
A Early Phase 1 study testing topical 0.5% Timolol in people with Hemangioma and Infant, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy. Read more about this study
- Who is it for?
- Ages 1 month to 8 months
- Conditions the study is for
- Hemangioma, Infant
- What is being tested?
- topical 0.5% Timolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2014
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.
Who cannot join
- Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
- Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
- Subjects with IH measuring more than 3cm in size or ulcerated.
- Children with a history of hypersensitivity to beta blockers.
- Children with a personal history of asthma.
- Children with known renal impairment.
Show all 9Show fewer
- Children with known cardiac conditions that may predispose to heart block
- Personal history of hypoglycemia
- Children on medications that may interact with beta blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239-4501
About this study
Official title: Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
Read the detailed description
At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.
- Conditions
- Hemangioma, Infant
- Being tested
- topical 0.5% Timolol, Control (placebo) group
- Keywords
- topical 0.5% Timolol, infantile hemangioma (IH)
- Medical subject headings
- Hemangioma, Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical 0.5% TimololDrug
topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) groupDrug
Control (placebo) group
| Study group | Role | What they receive |
|---|---|---|
| Topical 0.5% Timolol | Active comparator | Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. Receives: Drug: topical 0.5% Timolol |
| Placebo | Placebo comparator | Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily Receives: Drug: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.
This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.
Measured: at 6 months
Secondary outcomes (1)
Compare Treatment Group to Control Group Improvement Assessments
- The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.
- The difference between the extent/size of the hemangioma as an outcome measure versus color changes.
- Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alfons Krol, MD, FRCPC, Oregon Health and Science University
- Investigators
- Alfons L. Krol, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147601
- Sponsor's protocol ID
- 6114
- Status last verified
- Apr 2017
- First submitted
- 14 Jun 2010
- Last updated
- 5 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01147601
- Acronym / sponsor ID
- 6114
- Conditions
- Hemangioma, Infant
- Keywords
- topical 0.5% Timolol, infantile hemangioma (IH)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 5 Jul 2017
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 learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
Detailed description
At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical 0.5% Timolol | Active comparator | Drug: topical 0.5% TimololHalf of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. |
| Placebo | Placebo comparator | Drug: Control (placebo) groupAqueous placebo, 2-3 drops to cover the hemangioma, twice daily |
Who may qualify
- Ages
- 1 month to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.
Key exclusion criteria (9 listed)
- Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
- Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
- Subjects with IH measuring more than 3cm in size or ulcerated.
- Children with a history of hypersensitivity to beta blockers.
- Children with a personal history of asthma.
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 |
|---|---|---|
| topical 0.5% Timololtopical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily | Drug | Topical 0.5% Timolol |
| Control (placebo) groupControl (placebo) group | Drug | Placebo |
Primary outcome
Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.
Time frame: at 6 months
This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.
1 secondary outcome
Compare Treatment Group to Control Group Improvement Assessments
Time frame: at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alfons L. Krol, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing topical 0.5% Timolol in people with Hemangioma and Infant, run by Oregon Health and Science University 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Jul 2017. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos. (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2017.