Infantile HemangiomaPhase 2NCT04684667
''Efficacy of Propranolol in the Treatment of Infantile Hemangioma"
A Phase 2 study testing Propranolol Therapy for Infantile Hemangioma in people with Infantile Hemangioma, run by Assiut University at 1 site in Egypt.
Trial summary
''Evaluation of the Efficacy of Propranolol in the Treatment of Infantile Hemangioma" Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Infantile Hemangioma
- What is being tested?
- Propranolol Therapy for Infantile Hemangioma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with problematic infantile hemangiomas:
- A-Large hemangiomas at increased risk of scarring or disfigurement at any site. B-Hemangiomas carrying functional risks near the eyes, nose, natural orifices, limbs, genitalia.
- C-Ulcerated infantile hemangiomas. D-Uncomplicated progressive infantile hemangiomas with unpredictable future course.
- E-Life-threatening hemangiomas.
- Multiple hemangiomas
Who cannot join
- Patients older than 1 year of age.
- Patients with heart diseases.
- Patients with history of bronchspasm or wheezing.
- Patients with Hypotension.
- Patients with Hypertension.
- Premature infants with corrected age less than 5 weeks.
Show all 9Show fewer
- Patients with conditions affecting blood glucose maintenance.
- Patients with liver failure.
- Patients with PHACES syndrome.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University Teaching Hospital
Asyut, 71526
Essam E.A Mowannas, MD, +201285289188
About this study
Official title: '' Efficacy of Propranolol in the Treatment of Infantile Hemangioma"
''Evaluation of the Efficacy of Propranolol in the Treatment of Infantile Hemangioma"
Read the detailed description
Infantile hemangiomas (IH) are benign tumors of vascular endothelium.They are the most common tumors of infancy. They occur in about 4% of infants, though early studies were as high as 10%, probably due to the inclusion of other vascular lesions. The incidence is higher in premature infants, Caucasians, and females (by a 3 to 5:1 ratio). Advanced maternal age, multiple gestations, and placental abnormalities are also risk factors. IHs have a unique and characteristic life cycle consisting of three phases: proliferative, involuting, and involuted.
The majority of IHs do not require any specific treatment other than observation and reassurance of the parents. Even tumors that exhibit rapid growth or fiery red skin will spontaneously regress and leave behind little to no evidence of their presence. However, regular follow-up is important as the potential complications have few clinical indicators.
Reasons for treatment include dangerous locations (impinging on a vital structure such as the airway or eye), unusually large size or rapid growth, and local or endangering complications (skin ulceration or high-output heart failure). Hemangiomas exhibiting the aforementioned risk factors or complications should be considered for treatment. As hemangiomas are tumors of pure angiogenesis, pharmacologic therapy involves angiogenesis inhibition.
Historically, steroids have been used as the primary treatment for IH. Steroids have been shown to be antiangiogenic in a number of in vitro settings and also have shown good therapeutic effects clinically. However, the use of steroids may lead to various complications including gastroesophageal reflux and growth disorders, although these complications are associated with long-term use and high dose. A type of anticancer drug or immunomodulator, interferon alfa, may be used for severe IH in cases where patients did not respond to steroids. However, interferon alfa also has several possible adverse effects, including fever, muscle pain, systemic myalgia, and in severe cases, liver damage, blood toxic effects, thyroid hormonal abnormality, and neurological and neurodevelopmental toxic effects. Because of concerns about these adverse effects, many guardians of pediatric patients prefer to wait rather than accept treatment.
Propranolol, a nonselective beta blocker, has recently been recognized as an important treatment option for hemangiomas. In most centers, it has become first-line pharmacotherapy. A child with a nasal capillary hemangioma treated with propranolol for steroid-induced cardiomyopathy had regression of his lesion. This revelation led to the publication of several more studies supporting this finding. Propranolol is given orally at 2-3 mg/kg/day, in two or three divided doses, and discontinued following regression of the lesion. Treatment often leads to a consistent, rapid, therapeutic effect with softening of the lesion on palpation and color shift from intense red to purple. Propranolol is well tolerated but can cause rare side effects such as bradycardia, gastroesophageal reflux, hypoglycemia, hypotension, rash, somnolence, and wheezing.
- Conditions
- Infantile Hemangioma
- Being tested
- Propranolol Therapy for Infantile Hemangioma
- Keywords
- Hemangioma, Propranolol, Beta Blockers
- Medical subject headings
- Hemangioma, Capillary, Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol Therapy for Infantile HemangiomaDrug
Also called Propranolol Treatment for Infantile Hemangioma
If there are no contraindications to propranolol, it will be given at initial dose of 0.5 mg /kg/day in 2-3 divided doses with feeds and the patients will be observed for clinical signs of serious adverse reactions. If the dose is tolerated, it will be maintained for four to seven days, and then it will be increased by 0.5mg/kg/day every four days to the target dose of 2mg/kg/day. The patients will be observed for 2 hours after each dose increase for the clinical signs of severe side effects.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Therapy | Other | This arm will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021. Receives: Drug: Propranolol Therapy for Infantile Hemangioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical clearance of hemangioma or reduction of hemangioma's volume.
The efficacy of the treatment will be evaluated by complete clinical clearance of lesion (defined arbitrarily as >90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier for cutaneous infantile hemangiomas and by volume reduction of hemangiomas as evaluated by the proper imaging modalities ( Ultrasound, CT, or MRI) for non cutaneous hemangiomas.
Measured: within 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Ezzat Anees Mowannas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684667
- Sponsor's protocol ID
- Essam Mowannas
- Status last verified
- Dec 2020
- First submitted
- 29 Apr 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD.
Publications
Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY, and SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma. Pediatrics. 2015 Oct;136(4):e1060-104. doi: 10.1542/peds.2015-2485.
PubMed 26416931Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD & NECK SURGERY, AND SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma: Executive Summary. Pediatrics. 2015 Oct;136(4):786-91. doi: 10.1542/peds.2015-2482. No abstract available.
PubMed 26416928Leaute-Labreze C, Harper JI, Hoeger PH. Infantile haemangioma. Lancet. 2017 Jul 1;390(10089):85-94. doi: 10.1016/S0140-6736(16)00645-0. Epub 2017 Jan 13.
PubMed 28089471HOLMDAHL K. Cutaneous hemangiomas in premature and mature infants. Acta Paediatr (Stockh). 1955 Jul;44(4):370-9. doi: 10.1111/j.1651-2227.1955.tb04151.x. No abstract available.
PubMed 13292246Amir J, Metzker A, Krikler R, Reisner SH. Strawberry hemangioma in preterm infants. Pediatr Dermatol. 1986 Sep;3(4):331-2. doi: 10.1111/j.1525-1470.1986.tb00535.x.
PubMed 3774653Hemangioma Investigator Group; Haggstrom AN, Drolet BA, Baselga E, Chamlin SL, Garzon MC, Horii KA, Lucky AW, Mancini AJ, Metry DW, Newell B, Nopper AJ, Frieden IJ. Prospective study of infantile hemangiomas: demographic, prenatal, and perinatal characteristics. J Pediatr. 2007 Mar;150(3):291-4. doi: 10.1016/j.jpeds.2006.12.003.
PubMed 17307549Margileth AM, Museles M. Cutaneous hemangiomas in children. Diagnosis and conservative management. JAMA. 1965 Nov 1;194(5):523-6. No abstract available.
PubMed 5897362Bennett ML, Fleischer AB Jr, Chamlin SL, Frieden IJ. Oral corticosteroid use is effective for cutaneous hemangiomas: an evidence-based evaluation. Arch Dermatol. 2001 Sep;137(9):1208-13. doi: 10.1001/archderm.137.9.1208.
PubMed 11559219Greenberger S, Boscolo E, Adini I, Mulliken JB, Bischoff J. Corticosteroid suppression of VEGF-A in infantile hemangioma-derived stem cells. N Engl J Med. 2010 Mar 18;362(11):1005-13. doi: 10.1056/NEJMoa0903036.
PubMed 20237346Crum R, Szabo S, Folkman J. A new class of steroids inhibits angiogenesis in the presence of heparin or a heparin fragment. Science. 1985 Dec 20;230(4732):1375-8. doi: 10.1126/science.2416056.
PubMed 2416056Boon LM, MacDonald DM, Mulliken JB. Complications of systemic corticosteroid therapy for problematic hemangioma. Plast Reconstr Surg. 1999 Nov;104(6):1616-23. doi: 10.1097/00006534-199911000-00002.
PubMed 10541160Barlow CF, Priebe CJ, Mulliken JB, Barnes PD, Mac Donald D, Folkman J, Ezekowitz RA. Spastic diplegia as a complication of interferon Alfa-2a treatment of hemangiomas of infancy. J Pediatr. 1998 Mar;132(3 Pt 1):527-30. doi: 10.1016/s0022-3476(98)70034-4.
PubMed 9544915Deb G, Jenkner A, Donfrancesco A. Spastic diplegia and interferon. J Pediatr. 1999 Mar;134(3):382. doi: 10.1016/s0022-3476(99)70474-9. No abstract available.
PubMed 10064684Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.
PubMed 18550886Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
PubMed 19706583
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '' Efficacy of Propranolol in the Treatment of Infantile Hemangioma"
- ClinicalTrials.gov ID
- NCT04684667
- Acronym / sponsor ID
- Essam Mowannas
- Conditions
- Infantile Hemangioma
- Keywords
- Hemangioma, Propranolol, Beta Blockers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
''Evaluation of the Efficacy of Propranolol in the Treatment of Infantile Hemangioma"
Detailed description
Infantile hemangiomas (IH) are benign tumors of vascular endothelium.They are the most common tumors of infancy. They occur in about 4% of infants, though early studies were as high as 10%, probably due to the inclusion of other vascular lesions. The incidence is higher in premature infants, Caucasians, and females (by a 3 to 5:1 ratio). Advanced maternal age, multiple gestations, and placental abnormalities are also risk factors. IHs have a unique and characteristic life cycle consisting of three phases: proliferative, involuting, and involuted.
The majority of IHs do not require any specific treatment other than observation and reassurance of the parents. Even tumors that exhibit rapid growth or fiery red skin will spontaneously regress and leave behind little to no evidence of their presence. However, regular follow-up is important as the potential complications have few clinical indicators.
Reasons for treatment include dangerous locations (impinging on a vital structure such as the airway or eye), unusually large size or rapid growth, and local or endangering complications (skin ulceration or high-output heart failure). Hemangiomas exhibiting the aforementioned risk factors or complications should be considered for treatment. As hemangiomas are tumors of pure angiogenesis, pharmacologic therapy involves angiogenesis inhibition.
Historically, steroids have been used as the primary treatment for IH. Steroids have been shown to be antiangiogenic in a number of in vitro settings and also have shown good therapeutic effects clinically. However, the use of steroids may lead to various complications including gastroesophageal reflux and growth disorders, although these complications are associated with long-term use and high dose. A type of anticancer drug or immunomodulator, interferon alfa, may be used for severe IH in cases where patients did not respond to steroids. However, interferon alfa also has several possible adverse effects, including fever, muscle pain, systemic myalgia, and in severe cases, liver damage, blood toxic effects, thyroid hormonal abnormality, and neurological and neurodevelopmental toxic effects. Because of concerns about these adverse effects, many guardians of pediatric patients prefer to wait rather than accept treatment.
Propranolol, a nonselective beta blocker, has recently been recognized as an important treatment option for hemangiomas. In most centers, it has become first-line pharmacotherapy. A child with a nasal capillary hemangioma treated with propranolol for steroid-induced cardiomyopathy had regression of his lesion. This revelation led to the publication of several more studies supporting this finding. Propranolol is given orally at 2-3 mg/kg/day, in two or three divided doses, and discontinued following regression of the lesion. Treatment often leads to a consistent, rapid, therapeutic effect with softening of the lesion on palpation and color shift from intense red to purple. Propranolol is well tolerated but can cause rare side effects such as bradycardia, gastroesophageal reflux, hypoglycemia, hypotension, rash, somnolence, and wheezing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021.
| Arm | Type | Receives |
|---|---|---|
| Propranolol Therapy | Other | Drug: Propranolol Therapy for Infantile HemangiomaThis arm will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed with problematic infantile hemangiomas:
- A-Large hemangiomas at increased risk of scarring or disfigurement at any site. B-Hemangiomas carrying functional risks near the eyes, nose, natural orifices, limbs, genitalia.
- C-Ulcerated infantile hemangiomas. D-Uncomplicated progressive infantile hemangiomas with unpredictable future course.
- E-Life-threatening hemangiomas.
- Multiple hemangiomas
Key exclusion criteria (9 listed)
- Patients older than 1 year of age.
- Patients with heart diseases.
- Patients with history of bronchspasm or wheezing.
- Patients with Hypotension.
- Patients with Hypertension.
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 |
|---|---|---|
| Propranolol Therapy for Infantile HemangiomaAlso: Propranolol Treatment for Infantile HemangiomaIf there are no contraindications to propranolol, it will be given at initial dose of 0.5 mg /kg/day in 2-3 divided doses with feeds and the patients will be observed for clinical signs of serious adverse reactions. If the dose is tolerated, it will be maintained for four to seven days, and then it will be increased by 0.5mg/kg/day every four days to the target dose of 2mg/kg/day. The patients will be observed for 2 hours after each dose increase for the clinical signs of severe side effects. | Drug | Propranolol Therapy |
Primary outcome
Complete clinical clearance of hemangioma or reduction of hemangioma's volume.
Time frame: within 9 months
The efficacy of the treatment will be evaluated by complete clinical clearance of lesion (defined arbitrarily as >90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier for cutaneous infantile hemangiomas and by volume reduction of hemangiomas as evaluated by the proper imaging modalities ( Ultrasound, CT, or MRI) for non cutaneous hemangiomas.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Background: PubMed 26416931Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY, and SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma. Pediatrics. 2015 Oct;136(4):e1060-104. doi: 10.1542/peds.2015-2485.
- Background: PubMed 26416928Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD & NECK SURGERY, AND SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma: Executive Summary. Pediatrics. 2015 Oct;136(4):786-91. doi: 10.1542/peds.2015-2482. No abstract available.
- Background: PubMed 28089471Leaute-Labreze C, Harper JI, Hoeger PH. Infantile haemangioma. Lancet. 2017 Jul 1;390(10089):85-94. doi: 10.1016/S0140-6736(16)00645-0. Epub 2017 Jan 13.
- Background: PubMed 13292246HOLMDAHL K. Cutaneous hemangiomas in premature and mature infants. Acta Paediatr (Stockh). 1955 Jul;44(4):370-9. doi: 10.1111/j.1651-2227.1955.tb04151.x. No abstract available.
- Background: PubMed 3774653Amir J, Metzker A, Krikler R, Reisner SH. Strawberry hemangioma in preterm infants. Pediatr Dermatol. 1986 Sep;3(4):331-2. doi: 10.1111/j.1525-1470.1986.tb00535.x.
- Background: PubMed 17307549Hemangioma Investigator Group; Haggstrom AN, Drolet BA, Baselga E, Chamlin SL, Garzon MC, Horii KA, Lucky AW, Mancini AJ, Metry DW, Newell B, Nopper AJ, Frieden IJ. Prospective study of infantile hemangiomas: demographic, prenatal, and perinatal characteristics. J Pediatr. 2007 Mar;150(3):291-4. doi: 10.1016/j.jpeds.2006.12.003.
- Background: PubMed 5897362Margileth AM, Museles M. Cutaneous hemangiomas in children. Diagnosis and conservative management. JAMA. 1965 Nov 1;194(5):523-6. No abstract available.
- Background: PubMed 11559219Bennett ML, Fleischer AB Jr, Chamlin SL, Frieden IJ. Oral corticosteroid use is effective for cutaneous hemangiomas: an evidence-based evaluation. Arch Dermatol. 2001 Sep;137(9):1208-13. doi: 10.1001/archderm.137.9.1208.
- Background: PubMed 20237346Greenberger S, Boscolo E, Adini I, Mulliken JB, Bischoff J. Corticosteroid suppression of VEGF-A in infantile hemangioma-derived stem cells. N Engl J Med. 2010 Mar 18;362(11):1005-13. doi: 10.1056/NEJMoa0903036.
- Background: PubMed 2416056Crum R, Szabo S, Folkman J. A new class of steroids inhibits angiogenesis in the presence of heparin or a heparin fragment. Science. 1985 Dec 20;230(4732):1375-8. doi: 10.1126/science.2416056.
- Background: PubMed 10541160Boon LM, MacDonald DM, Mulliken JB. Complications of systemic corticosteroid therapy for problematic hemangioma. Plast Reconstr Surg. 1999 Nov;104(6):1616-23. doi: 10.1097/00006534-199911000-00002.
- Background: PubMed 9544915Barlow CF, Priebe CJ, Mulliken JB, Barnes PD, Mac Donald D, Folkman J, Ezekowitz RA. Spastic diplegia as a complication of interferon Alfa-2a treatment of hemangiomas of infancy. J Pediatr. 1998 Mar;132(3 Pt 1):527-30. doi: 10.1016/s0022-3476(98)70034-4.
- Individual participant dataSharing planned: Yes. all collected IPD.
Related trials for Infantile Hemangioma
RecruitingPhase 2/3
Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma
Infantile Hemangioma
Not yet recruitingObservational study
Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth
Infantile Hemangioma (IH)
Not yet recruitingPhase 4
Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
Infantile Hemangioma (IH)
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.
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 Propranolol Therapy for Infantile Hemangioma in people with Infantile Hemangioma, run by Assiut University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 24 Dec 2020. 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 Egypt. 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 Essam EA Mowannas, MD (+201285289188, essamezzat81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical clearance of hemangioma or reduction of hemangioma's volume. (time frame: within 9 months). 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 NCT04684667, which also lists 20 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 24 Dec 2020.