Tacrolimus, Kaposiform Hemangioendothelioma, Tufted AngiomaPhase 2NCT04056962
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma
A Phase 2 study testing Tacrolimus ointment in people with Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma, run by West China Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
- What is being tested?
- Tacrolimus ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 28 Oct 2024
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
Who cannot join
- Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yi Ji, MD, 86 18980606865, jijiyuanyuan@163.com
About this study
Official title: Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma：a Randomized Controlled Study
The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
Read the detailed description
Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
- Being tested
- Tacrolimus ointment
- Medical subject headings
- Kaposiform Hemangioendothelioma, Tufted angioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
topical application of tacrolimus at different concentrations for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
| Study group | Role | What they receive |
|---|---|---|
| patients treated with tacrolimus 0.03% ointment | Experimental | patients treated with tacrolimus 0.03% ointment Receives: Drug: Tacrolimus ointment |
| patients treated with tacrolimus 0.1% ointment | Active comparator | patients treated with tacrolimus 0.1% ointment Receives: Drug: Tacrolimus ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the size of the lesion
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
Measured: 2.5 years
Secondary outcomes (1)
Rate of Adverse events
using the measurement of ratio to evaluate the rate of adverse events of topical application of tacrolimus (such as ratio of Acne vulgaris, pruritis and rash etc.).
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Aug 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tacrolimus, Kaposiform Hemangioendothelioma, Tufted AngiomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
- Investigators
- Yi Ji, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056962
- Sponsor's protocol ID
- 813
- Status last verified
- May 2024
- First submitted
- 11 Aug 2019
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04056962
- Acronym / sponsor ID
- 813
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 14 Aug 2019 (actual)
- 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 aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
Detailed description
Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated with tacrolimus 0.03% ointment | Experimental | Drug: Tacrolimus ointmentpatients treated with tacrolimus 0.03% ointment |
| patients treated with tacrolimus 0.1% ointment | Active comparator | Drug: Tacrolimus ointmentpatients treated with tacrolimus 0.1% ointment |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
Key exclusion criteria (1 listed)
- Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
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 |
|---|---|---|
| Tacrolimus ointmenttopical application of tacrolimus at different concentrations for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA). | Drug | patients treated with tacrolimus 0.03% ointment, patients treated with tacrolimus 0.1% ointment |
Primary outcome
reduction in the size of the lesion
Time frame: 2.5 years
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
1 secondary outcome
Rate of Adverse events
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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.
Yi Ji principal investigator
West China Hospital
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 Tacrolimus ointment in people with Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma, run by West China Hospital at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ji, PHD, MD (+86 13980544622, jijiyuanyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the size of the lesion (time frame: 2.5 years). 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 7 May 2024.