| CTRI Number |
CTRI/2025/12/099585 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [moisturizer lotion with probiotics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a new Aloe vera moisturizer with probiotics to see how well it works and whether it causes any side effects |
|
Scientific Title of Study
|
Development and Validation of BIOMOIST- Moisturizer from Aleovera Added
with Probiotics. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college hospital |
| Address |
ward number 120, 1st floor, department of paediatrics, saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai,
Chennai
TAMIL NADU
602105
India |
| Phone |
8333826150 |
| Fax |
|
| Email |
vcr.akash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navin umapathy |
| Designation |
Assistant professor |
| Affiliation |
Saveetha medical college hospital |
| Address |
ward number 120, 1st floor , department of paediatrics,saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9487002379 |
| Fax |
|
| Email |
navinu.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college hospital |
| Address |
ward number 120, 1st floor , department of paediatrics,saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8333826150 |
| Fax |
|
| Email |
vcr.akash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college hospital |
| Address |
162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105 |
| Type of Sponsor |
Private 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 akash |
Saveetha medical college hospital |
Ward number 120, 1st floor , Department of Paediatrics
Chennai
TAMIL NADU |
8333826150
vcr.akash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOMOIST (Aloe vera–based moisturizer with probiotics) |
Topical application of a moisturizer formulated using Aloe vera gel, Virgin coconut oil, and Lactobacillus rhamnosus (0.5%) applied over affected areas three times a day for a period of 4 weeks.It was assessed at baseline and after 4 weeks of intervention |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 6 months and 5 years with a clinical diagnosis of dermatitis considered suitable for topical therapy were eligible for inclusion. Only patients with limited disease involvement, defined as target lesions affecting not more than 10 percent of the total body surface area, were enrolled. Lesions were required to be located on the trunk or extremities. Written informed consent was obtained from the parent or legal guardian prior to inclusion in the study. |
|
| ExclusionCriteria |
| Details |
Children with a known history of hypersensitivity to Aloe vera, probiotics, or any of the formulation excipients were excluded. Patients presenting with infected, ulcerated, or actively weeping skin lesions were not considered for enrolment. Those with severe chronic dermatological conditions requiring systemic therapy, as well as children receiving systemic corticosteroids or other immunosuppressive medications, were also excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pruritus score
Improvement in skin condition score (SCORAD) |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sleep quality,
Caregiver satisfaction,
Treatment adherence |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This prospective, open-label pilot study aims to develop and validate a novel Aloe vera–based moisturizer enriched with probiotics (BIOMOIST) for the management of pediatric dermatitis. Children aged 6 months to 5 years with mild to moderate dermatitis will receive topical application of the formulation. Outcomes will include improvement in pruritus, skin condition scores, sleep quality, and caregiver satisfaction. The study seeks to evaluate safety, feasibility, and preliminary efficacy of the formulation. |