HemangiomaPhase 2NCT02731287
Topical Timolol for Infantile Hemangioma in Early Proliferative Phase
A Phase 2 study testing Timolol in people with Hemangioma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH… Read more about this study
- Who is it for?
- Ages 10 to 60 days
- Conditions the study is for
- Hemangioma
- What is being tested?
- Timolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2014to Mar 2017
- 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 10 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s),
- The patient is between 10 and 60 days of age at the time of enrollment,
- The patient should have:
- at least one focal or segmental hemangioma, mixed or superficial, present anywhere on the body of at least 0.3 cm of minimum diameter and not greater of 5 cm.
- abortive or minimal growth hemangioma
- Infantile hemangioma precursors
Who cannot join
- Patients > 60 days of age
- Complicated hemangiomas (life-threatening, function-threatening, or ulcerated)
- Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser.
- Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome.
- Internal involvement hemangiomas (liver, GI tract, larynx)
- Children with a personal history of asthma or cardiac conditions that may predispose to heart block.
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- Children with congenital birth defects
- Children with Cancer (leukemia, sarcoma, neuroblastoma, retinoblastoma)
- Children with a history of hypersensitivity to beta blockers or excipients.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Virgen del Rocío
Seville, 41013
About this study
Official title: Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.
Read the detailed description
A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of infantile hemangioma.
Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks.
Changes in lesion size, color and thickness will be evaluated from photographs taken at 2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit. Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale (complete resolution, improve, stabilization, worsening).
- Conditions
- Hemangioma
- Being tested
- Timolol, Placebo
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
Also called Timolol maleate 0.5%
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
PlaceboDrug
Also called Saline Solution
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Experimental | Timolol maleate 0.5% topical solution; 50% of the patients treated (randomized) Receives: Drug: Timolol |
| Placebo | Placebo comparator | Saline topical solution; 50% of the patients treated (randomized) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete or almost complete resolution of the lesions
Efficacy to treatment at 24 weeks, categorized as complete or almost complete resolution of the lesions (almost complete resolution defined as faint macular erythema, telangiectasia and no palpable component).
This will be generated by independent blind evaluations by comparing photographs at baseline and 24 weeks. The investigators will score this improvement into one of the following categories (complete resolution, improve, stabilization, worsening)
Measured: 24 weeks
Secondary outcomes (1)
Adverse reactions
Evaluation of safety and adverse reactions. The investigators will monitor vital signs of the patients every follow-up visit and ask the caretakers about side effects and adverse reactions to treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2014
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eulalia Baselga, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731287
- Sponsor's protocol ID
- IIBSP-TIM-2013-156
- Status last verified
- Nov 2018
- First submitted
- 17 Nov 2015
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02731287
- Acronym / sponsor ID
- IIBSP-TIM-2013-156
- Conditions
- Hemangioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Apr 2016 (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.
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.
Detailed description
A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of infantile hemangioma.
Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks.
Changes in lesion size, color and thickness will be evaluated from photographs taken at 2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit. Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale (complete resolution, improve, stabilization, worsening).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Experimental | Drug: TimololTimolol maleate 0.5% topical solution; 50% of the patients treated (randomized) |
| Placebo | Placebo comparator | Drug: PlaceboSaline topical solution; 50% of the patients treated (randomized) |
Who may qualify
- Ages
- 10 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s),
- The patient is between 10 and 60 days of age at the time of enrollment,
- The patient should have:
Key exclusion criteria (9 listed)
- Patients > 60 days of age
- Complicated hemangiomas (life-threatening, function-threatening, or ulcerated)
- Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser.
- Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome.
- Internal involvement hemangiomas (liver, GI tract, larynx)
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 |
|---|---|---|
| TimololAlso: Timolol maleate 0.5%The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks | Drug | Timolol |
| PlaceboAlso: Saline SolutionThe patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks | Drug | Placebo |
Primary outcome
Complete or almost complete resolution of the lesions
Time frame: 24 weeks
Efficacy to treatment at 24 weeks, categorized as complete or almost complete resolution of the lesions (almost complete resolution defined as faint macular erythema, telangiectasia and no palpable component). This will be generated by independent blind evaluations by comparing photographs at baseline and 24 weeks. The investigators will score this improvement into one of the following categories (complete resolution, improve, stabilization, worsening)
1 secondary outcome
Adverse reactions
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
Eulalia Baselga, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2 sites 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 in people with Hemangioma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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 6 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: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete or almost complete resolution of the lesions (time frame: 24 weeks). 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 14 Nov 2018.