Infantile Hemangioma (IH)IH-MAGRSTNCT07669545
Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth
An observational study of Infantile Hemangioma (IH), run by West China Hospital at 1 site in China.
Trial summary
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Infantile Hemangioma (IH)
- What is being tested?
- Routine Clinical Assessment and Risk Stratification
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2026to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic and are clinically diagnosed with either infantile hemangioma with minimal or arrested growth or classic infantile hemangioma. Participants will be enrolled prospectively and followed as two observational cohorts.
Who may be able to join
- Infants clinically diagnosed with infantile hemangioma, including minimal or arrested growth infantile hemangioma and classic infantile hemangioma.
- Participants undergoing their initial specialist evaluation at the study center.
- Age at baseline: from birth to 24 months.
- Sufficient clinical information available for baseline assessment, including lesion location, morphology, size, number of lesions, complications, and treatment recommendation.
- Parents or legal guardians are able to understand the study procedures and provide written informed consent.
Who cannot join
- Patients with vascular anomalies other than infantile hemangioma, including vascular malformations, congenital hemangioma, kaposiform hemangioendothelioma, pyogenic granuloma, or other vascular tumors.
- Patients with insufficient clinical information to determine the infantile hemangioma subtype, AAP risk category, Hemangioma Severity Scale score, or baseline treatment recommendation.
- Patients who have received systemic pharmacologic treatment, procedural treatment, laser therapy, or surgical treatment for infantile hemangioma before the baseline specialist evaluation.
- Patients with severe comorbidities or unstable medical conditions that may interfere with clinical assessment or follow-up.
- Parents or legal guardians who decline participation or are unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Infantile Hemangioma With Minimal or Arrested Growth Versus Typical Infantile Hemangioma: A Prospective Cohort Study of Risk Stratification and Treatment Decision-Making
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent disfigurement, or structural anomalies.
This prospective observational cohort study will compare infants with IH-MAG and infants with classic infantile hemangioma at their first specialist evaluation. Each participant will undergo routine clinical assessment, standardized photography, risk classification according to the 2019 American Academy of Pediatrics guideline, and Hemangioma Severity Scale scoring. The main outcome is the initial management recommendation after specialist assessment, categorized as active management or treatment versus observation. The study will not assign any treatment. All management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.
Read the detailed description
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a distinct clinical subtype of infantile hemangioma characterized by early-onset vascular lesions with minimal or absent proliferative growth. IH-MAG may be mistaken for capillary malformation or other vascular anomalies because of its relatively subtle growth pattern. However, some IH-MAG lesions, particularly segmental lesions or lesions in high-risk anatomic sites, may still be associated with ulceration, functional impairment, permanent disfigurement, or syndromic structural anomalies.
Standardized tools, including the 2019 American Academy of Pediatrics risk classification and the Hemangioma Severity Scale, are widely used to assess risk and severity in infantile hemangioma. Their clinical value has been studied in infantile hemangiomas overall, but their distribution and decision-making value in IH-MAG remain insufficiently defined.
This is a single-center, prospective, observational comparative cohort study. Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic will be enrolled if they are clinically diagnosed with IH-MAG or classic infantile hemangioma and meet the eligibility criteria. Participants will be assigned to two observational cohorts: an IH-MAG cohort and a classic infantile hemangioma cohort. No treatment will be assigned by the study protocol.
At baseline, demographic information, lesion characteristics, standardized clinical photographs, AAP risk category, Hemangioma Severity Scale score, and the clinician's initial management recommendation will be recorded. The primary outcome is the initial management recommendation after the first specialist assessment, categorized as active management or treatment versus observation. Active management may include topical therapy, systemic therapy, laser therapy, surgery, local treatment, imaging evaluation, specialist referral, or multidisciplinary assessment when clinically indicated. Observation refers to regular follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active management at baseline.
Secondary outcomes include the distribution of AAP risk categories, Hemangioma Severity Scale scores, treatment intensity, reasons for treatment recommendation, use of imaging or specialist screening, changes in the management plan during follow-up, and diagnostic reclassification of suspected IH-MAG. Follow-up information will be collected at approximately 1, 3, and 6 months after baseline to document management implementation, lesion changes, complications, treatment adjustment, and diagnostic stability.
- Conditions
- Infantile Hemangioma (IH)
- Being tested
- Routine Clinical Assessment and Risk Stratification
- Keywords
- Infantile Hemangioma With Minimal or Arrested Growth, infantile hemangioma
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical Assessment and Risk StratificationOther
Participants will undergo routine specialist evaluation, standardized clinical photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up data collection. Initial management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment. No treatment is assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| IH-MAG Cohort | Infants clinically diagnosed with infantile hemangioma with minimal or arrested growth at the first specialist evaluation. IH-MAG is defined as an early-onset vascular lesion with minimal or absent proliferative growth, with proliferative components involving less than 25% of the total lesion area. Participants in this cohort will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol. Receives: Other: Routine Clinical Assessment and Risk Stratification | |
| Typical Infantile Hemangioma Cohort | Infants clinically diagnosed with typical infantile hemangioma at the first specialist evaluation who do not meet the diagnostic criteria for infantile hemangioma with minimal or arrested growth. This cohort may include superficial, deep, mixed, focal, segmental, or multifocal infantile hemangiomas. Participants will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol. Receives: Other: Routine Clinical Assessment and Risk Stratification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation
The proportion of participants for whom active management is recommended at baseline, defined as the initial specialist evaluation on Day 0. Active management is defined as any recommendation for pharmacologic treatment, procedural treatment, imaging evaluation, specialist referral, or multidisciplinary assessment based on guideline-based risk assessment. Observation is defined as scheduled follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active evaluation at baseline.
Measured: Baseline (Day 0)
Secondary outcomes (3)
Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline
The distribution of participants across prespecified risk categories according to the 2019 American Academy of Pediatrics clinical practice guideline for infantile hemangioma. Participants will be classified as highest risk, high risk, intermediate risk, or low risk based on lesion size, anatomic location, morphology, number of lesions, and risk of complications.
Measured: Baseline (Day 0)
Hemangioma Severity Scale Total Score at Baseline
The Hemangioma Severity Scale total score at baseline. The Hemangioma Severity Scale is used to assess the overall clinical severity of infantile hemangioma and includes objective and subjective components, including lesion size, anatomic location, risk of associated structural anomalies, complications, pain, and risk of disfigurement. The total score ranges from 0 to 51, with higher scores indicating greater hemangioma severity and a worse clinical outcome.
Measured: Baseline (Day 0)
Distribution of Baseline Hemangioma Severity Scale Categories
The distribution of participants across prespecified Hemangioma Severity Scale categories based on the baseline Hemangioma Severity Scale total score. The Hemangioma Severity Scale total score ranges from 0 to 51, with higher scores indicating greater hemangioma severity and a worse clinical outcome. Categories are defined as follows: 5 or lower, 6 to 10, and 11 or higher.
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infantile Hemangioma (IH)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669545
- Sponsor's protocol ID
- RCT20260621
- Acronym
- IH-MAGRST
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suh KY, Frieden IJ. Infantile hemangiomas with minimal or arrested growth: a retrospective case series. Arch Dermatol. 2010 Sep;146(9):971-6. doi: 10.1001/archdermatol.2010.197.
PubMed 20855695Haggstrom AN, Beaumont JL, Lai JS, Adams DM, Drolet BA, Frieden IJ, Garzon MC, Holland KE, Horii KA, Lucky AW, Mancini AJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Siegel D, Swigonski NL, Cella D, Chamlin SL. Measuring the severity of infantile hemangiomas: instrument development and reliability. Arch Dermatol. 2012 Feb;148(2):197-202. doi: 10.1001/archdermatol.2011.926.
PubMed 22351819Krowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475.
PubMed 30584062
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infantile Hemangioma With Minimal or Arrested Growth Versus Typical Infantile Hemangioma: A Prospective Cohort Study of Risk Stratification and Treatment Decision-Making
- ClinicalTrials.gov ID
- NCT07669545
- Acronym / sponsor ID
- IH-MAGRST / RCT20260621
- Conditions
- Infantile Hemangioma (IH)
- Keywords
- Infantile Hemangioma With Minimal or Arrested Growth, infantile hemangioma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 25 Jun 2026 (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.
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent disfigurement, or structural anomalies.
This prospective observational cohort study will compare infants with IH-MAG and infants with classic infantile hemangioma at their first specialist evaluation. Each participant will undergo routine clinical assessment, standardized photography, risk classification according to the 2019 American Academy of Pediatrics guideline, and Hemangioma Severity Scale scoring. The main outcome is the initial management recommendation after specialist assessment, categorized as active management or treatment versus observation. The study will not assign any treatment. All management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.
Detailed description
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a distinct clinical subtype of infantile hemangioma characterized by early-onset vascular lesions with minimal or absent proliferative growth. IH-MAG may be mistaken for capillary malformation or other vascular anomalies because of its relatively subtle growth pattern. However, some IH-MAG lesions, particularly segmental lesions or lesions in high-risk anatomic sites, may still be associated with ulceration, functional impairment, permanent disfigurement, or syndromic structural anomalies.
Standardized tools, including the 2019 American Academy of Pediatrics risk classification and the Hemangioma Severity Scale, are widely used to assess risk and severity in infantile hemangioma. Their clinical value has been studied in infantile hemangiomas overall, but their distribution and decision-making value in IH-MAG remain insufficiently defined.
This is a single-center, prospective, observational comparative cohort study. Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic will be enrolled if they are clinically diagnosed with IH-MAG or classic infantile hemangioma and meet the eligibility criteria. Participants will be assigned to two observational cohorts: an IH-MAG cohort and a classic infantile hemangioma cohort. No treatment will be assigned by the study protocol.
At baseline, demographic information, lesion characteristics, standardized clinical photographs, AAP risk category, Hemangioma Severity Scale score, and the clinician's initial management recommendation will be recorded. The primary outcome is the initial management recommendation after the first specialist assessment, categorized as active management or treatment versus observation. Active management may include topical therapy, systemic therapy, laser therapy, surgery, local treatment, imaging evaluation, specialist referral, or multidisciplinary assessment when clinically indicated. Observation refers to regular follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active management at baseline.
Secondary outcomes include the distribution of AAP risk categories, Hemangioma Severity Scale scores, treatment intensity, reasons for treatment recommendation, use of imaging or specialist screening, changes in the management plan during follow-up, and diagnostic reclassification of suspected IH-MAG. Follow-up information will be collected at approximately 1, 3, and 6 months after baseline to document management implementation, lesion changes, complications, treatment adjustment, and diagnostic stability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IH-MAG Cohort | – | Other: Routine Clinical Assessment and Risk StratificationInfants clinically diagnosed with infantile hemangioma with minimal or arrested growth at the first specialist evaluation. IH-MAG is defined as an early-onset vascular lesion with minimal or absent proliferative growth, with proliferative components involving less than 25% of the total lesion area. Participants in this cohort will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol. |
| Typical Infantile Hemangioma Cohort | – | Other: Routine Clinical Assessment and Risk StratificationInfants clinically diagnosed with typical infantile hemangioma at the first specialist evaluation who do not meet the diagnostic criteria for infantile hemangioma with minimal or arrested growth. This cohort may include superficial, deep, mixed, focal, segmental, or multifocal infantile hemangiomas. Participants will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic and are clinically diagnosed with either infantile hemangioma with minimal or arrested growth or classic infantile hemangioma. Participants will be enrolled prospectively and followed as two observational cohorts.
Key inclusion criteria (5 listed)
- Infants clinically diagnosed with infantile hemangioma, including minimal or arrested growth infantile hemangioma and classic infantile hemangioma.
- Participants undergoing their initial specialist evaluation at the study center.
- Age at baseline: from birth to 24 months.
- Sufficient clinical information available for baseline assessment, including lesion location, morphology, size, number of lesions, complications, and treatment recommendation.
- Parents or legal guardians are able to understand the study procedures and provide written informed consent.
Key exclusion criteria (5 listed)
- Patients with vascular anomalies other than infantile hemangioma, including vascular malformations, congenital hemangioma, kaposiform hemangioendothelioma, pyogenic granuloma, or other vascular tumors.
- Patients with insufficient clinical information to determine the infantile hemangioma subtype, AAP risk category, Hemangioma Severity Scale score, or baseline treatment recommendation.
- Patients who have received systemic pharmacologic treatment, procedural treatment, laser therapy, or surgical treatment for infantile hemangioma before the baseline specialist evaluation.
- Patients with severe comorbidities or unstable medical conditions that may interfere with clinical assessment or follow-up.
- Parents or legal guardians who decline participation or are unable to provide informed consent.
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 |
|---|---|---|
| Routine Clinical Assessment and Risk StratificationParticipants will undergo routine specialist evaluation, standardized clinical photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up data collection. Initial management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment. No treatment is assigned by the study protocol. | Other | IH-MAG Cohort, Typical Infantile Hemangioma Cohort |
Primary outcome
Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation
Time frame: Baseline (Day 0)
The proportion of participants for whom active management is recommended at baseline, defined as the initial specialist evaluation on Day 0. Active management is defined as any recommendation for pharmacologic treatment, procedural treatment, imaging evaluation, specialist referral, or multidisciplinary assessment based on guideline-based risk assessment. Observation is defined as scheduled follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active evaluation at baseline.
3 secondary outcomes
Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline
Time frame: Baseline (Day 0)
Hemangioma Severity Scale Total Score at Baseline
Time frame: Baseline (Day 0)
Distribution of Baseline Hemangioma Severity Scale Categories
Time frame: Baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 20855695Suh KY, Frieden IJ. Infantile hemangiomas with minimal or arrested growth: a retrospective case series. Arch Dermatol. 2010 Sep;146(9):971-6. doi: 10.1001/archdermatol.2010.197.
- Background: PubMed 22351819Haggstrom AN, Beaumont JL, Lai JS, Adams DM, Drolet BA, Frieden IJ, Garzon MC, Holland KE, Horii KA, Lucky AW, Mancini AJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Siegel D, Swigonski NL, Cella D, Chamlin SL. Measuring the severity of infantile hemangiomas: instrument development and reliability. Arch Dermatol. 2012 Feb;148(2):197-202. doi: 10.1001/archdermatol.2011.926.
- Background: PubMed 30584062Krowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Hemangioma (IH), 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Ji, PhD MD (862885423453, jijiyuanyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation (time frame: Baseline (Day 0)). 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 NCT07669545, which also lists 3 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 2 Jul 2026.