| CTRI Number |
CTRI/2025/03/081726 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of virgin coconut oil nanoparticles with ceramides and vitamin D as an alternative treatment modality for use in Icthyosis in Children aged 5 -15 years |
|
Scientific Title of Study
|
Use of lipid nanoparticles of virgin coconut oil complexed with ceramides and vitamin D for use in Icthyosis in children aged 5-15 years and to compare its effects to commercially available preparations. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suenera Kathrine P V |
| Designation |
Post graduate paediatrics |
| Affiliation |
saveetha medical college and hospital |
| Address |
Department of paediatrics ,first floor ,saveetha medical college and hospital ,Thandalam ,Kancheepuram district
Kancheepuram
Tamil Nadu
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
6380134147 |
| Fax |
|
| Email |
pvsk.med@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kishore.N |
| Designation |
Professor |
| Affiliation |
Saveetha medical college |
| Address |
Department of paediatrics ,first floor ,saveetha medical college and hospital ,Thandalam ,Kancheepuram district
Kancheepuram
Tamil Nadu
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9962560255 |
| Fax |
|
| Email |
kishore.ssp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Kishore.N |
| Designation |
Professor |
| Affiliation |
Saveetha medical college |
| Address |
Department of paediatrics ,first floor ,saveetha medical college and hospital ,Thandalam ,Kancheepuram district
Kancheepuram
Tamil Nadu
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9962560255 |
| Fax |
|
| Email |
kishore.ssp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital ,Saveetha nagar ,Thandalam ,Kancheepuram district ,Tamil Nadu-602015 |
|
|
Primary Sponsor
|
| Name |
SUENERA KATHRINE P V |
| Address |
Saveetha medical college and hospital ,Saveetha nagar ,Thandalam ,Kancheepuram district ,Tamil Nadu-602015 |
| Type of Sponsor |
Other [SELF] |
|
|
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 SUENERA KATHRINE PV |
Saveetha Hopspital |
Department of paediatrics ,first floor ,saveetha medical college and hospital ,Thandalam ,Kancheepuram district
Kancheepuram
Tamil Nadu
602105
India
Kancheepuram
TAMIL NADU |
6380134147
pvsk.med@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical college and hospital Institutional Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q800||Ichthyosis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standardized treatment modalities available for icthyosis |
This group of children will be given the standardized treatment modalities available for icthyosis daily for a period of 1 month and results will be analyzed.amount of product applies will depend on the area affected |
| Intervention |
Virgin nano oil |
This nanoparticles oil will be applied on the affected area of skin daily for a period of 1 month and results are analyzed with the help of visual index for icthyosis severity.amount of product applied will depend on the affected area |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric population from 5-15 years will be included in the study |
|
| ExclusionCriteria |
| Details |
1.children with severe forms of icthyosis requiring systemic treatment
2.presence of other concurrent skin conditions
3.recent use of systemic retinoids in the past 3 months
4.immunocompromised
5.children with underlying medical condition such as renal or hepatic impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.primary outcome of this study would likely focus on clinical improvement in Ichthyosis symptoms,as evaluated by visual index for ichthyosis severity
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improves overall skin health and skin hydration in children |
1 month |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pvsk.med@gmail.com].
- For how long will this data be available start date provided 05-03-2025 and end date provided 30-09-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ichthyosis is a hereditary skin
disorder resulting in chronic dry skin .It is characterized by a keratinization
defect resulting in chronic dry skin .Icthyosis vulgaris is caused by the loss of
function mutation in the filaggrin gene.This leads to loss of epidermal barrier leading to increased loss of transepidermal water.This study aims to utilize the anti inflammatory and hydrating properties of virgin coconut oil .By using nanoparticles of virgin coconut oil with ceramides ,it ensures
delivery to skins deepest layers ,and helps retain moisture.This research is considered as a randomized ,single blinded parallel group study ,focussing on reducing scaling and dryness of the affected area .The results are analyzed with the help of Visual index for icthyosis severity
|