| CTRI Number |
CTRI/2023/08/056626 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the role of intralesional bleomycin in cases of capillary hemangioma unresponsive to oral propranolol |
|
Scientific Title of Study
|
To evaluate the role of intralesional bleomycin in cases of periocular capillary hemangioma unresponsive to oral propranolol |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Kumar |
| Designation |
Junior resident - department of ophthalmology |
| Affiliation |
AIIMS , new delhi |
| Address |
Room no. 483 unit 5 office , Dr Rajendra Prasad for ophthalmic sciences , AIIMS New Delhi
Central
DELHI
110029
India |
| Phone |
07838661654 |
| Fax |
|
| Email |
kumar10123abhishek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M.S.Bajaj |
| Designation |
Professor |
| Affiliation |
AIIMS , new delhi |
| Address |
ROOM NO. 484 (fourth floor), Dr rajendra Prasad for ophthalmic sciences , AIIMS Delhi , Ansari nagar
Central
DELHI
110029
India |
| Phone |
07838661654 |
| Fax |
|
| Email |
Msbajaj32@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S bajaj |
| Designation |
Professor ophthalmology |
| Affiliation |
AIIMS , new delhi |
| Address |
Room no. 484 , fourth floor Dr rajendra Prasad centre for ophthalmic sciences , AIIMS new delhi
Room no. 484 , Dr.Rajendra Prasad center for ophthalmic sciences, AIIMS New Delhi
Central
DELHI
110029
India |
| Phone |
07838661654 |
| Fax |
|
| Email |
Msbajaj32@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Rajendra Prasad center for ophthalmic sciences , AIIMS New Delhi
|
|
|
Primary Sponsor
|
| Name |
Rp center institute of ophthalmic sciences |
| Address |
AIIMS, new delhi, Ansari nagar 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MSbajaj |
All india institute of medical sciences , Delhi |
Dr.rajendra Prasad centre for ophthalmic sciences
Central
DELHI |
7838661654
Msbajaj32@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee for post graduate research , Aiims delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H028||Other specified disorders of eyelid, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intralesional bleomycin injection |
Dose 0.5mg/kg in less than 1 year old
Dose 1 IU/ml in age more than 1 year
Maximum of three injections 6 weeks apart
Maximum duration - 6 months |
| Comparator Agent |
not APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All periocular capillary hemangioma patients 0-18 years who are resistant to oral propranolol |
|
| ExclusionCriteria |
| Details |
Age > 18 years
Capillary hemangioma responding to oral propranolol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the area of the lesion , maximum horizontal diameter , maximum vertical diameter , color change , percentage of area reduction |
At baseline , 1 week , 4 weeks , 2 months , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in BCVA , percentage reduction in area |
2 weeks , 1 month , 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective interventional study to evaluate the role of intralesional bleomycin in patients of periocular hemangiomas unresponsive to oral propranolol .since surgery , corticosteroids and radiation therapy has side effects.Currently there is paucity of prospective interventional studies regarding the same.Retrospective studies showed benefit of the intralesional bleomycin injections |