Clinical trial · Observational
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities
Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas
NCT02061735CI-TRIAL-00017812completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangiomas | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- oral propranolol
- description
- Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.
- label
- timolol maleate 0.5% gel
- description
- One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.
- label
- No treatment, observation only
- description
- No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 5 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≤ 5 years of age * Diagnosis of a cutaneous infantile hemangioma * Diagnosis of hemangioma requiring treatment (treatment includes: propranolol or topical timolol) or diagnosis of an infantile hemangioma that will not be treated at the time of enrollment * Able to tolerate imaging procedures Exclusion Criteria: * Age \> 5 years * Non cutaneous infantile hemangioma * Hemangioma on the lip * Hemangioma on the eyelid * Hemangioma located in areas whereby measurements cannot be made due to equipment limitations * Deep hemangioma with no visible skin surface component * Congenital hemangioma * No available normal site for study control * Other vascular anomaly * Not able to tolerate imaging procedures
References
Publications (1)
- DERIVEDBurkes SA, Patel M, Adams DM, Hammill AM, Eaton KP, Randall Wickett R, Visscher MO. Infantile hemangioma status by dynamic infrared thermography: A preliminary study. Int J Dermatol. 2016 Oct;55(10):e522-32. doi: 10.1111/ijd.13298. Epub 2016 Apr 8. PMID 27062495