| CTRI Number |
CTRI/2025/07/091312 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A scientific study to check how well plant based moisturizers like Smoo Buttergel and Smoo Baby Lotion keep skin soft and hydrated compared to other popular products |
|
Scientific Title of Study
|
Evaluation of Skin Hydration Effectiveness of Plant-Based Moisturizers Smoo Buttergel and Smoo Baby Pure Moisturizing Lotion using Biophysical Methods and Comparison with Market Reference Products |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ragavi |
| Designation |
Consultant |
| Affiliation |
RENDER skin and hair |
| Address |
RENDER skin and hair, Canberra House, 97, Pantheon Road, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU
600008
India |
| Phone |
7708716948 |
| Fax |
|
| Email |
drragavi@renderclinic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ragavi |
| Designation |
Consultant |
| Affiliation |
RENDER skin and hair |
| Address |
RENDER skin and hair, Canberra House, 97, Pantheon Road, Egmore, Chennai, Tamil Nadu 600008
TAMIL NADU
600008
India |
| Phone |
7708716948 |
| Fax |
|
| Email |
drragavi@renderclinic.com |
|
Details of Contact Person
Public Query
|
| Name |
Ragavi |
| Designation |
Consultant |
| Affiliation |
RENDER skin and hair |
| Address |
RENDER skin and hair, Canberra House, 97, Pantheon Road, Egmore, Chennai, Tamil Nadu 600008
TAMIL NADU
600008
India |
| Phone |
7708716948 |
| Fax |
|
| Email |
drragavi@renderclinic.com |
|
|
Source of Monetary or Material Support
|
| RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008 |
|
|
Primary Sponsor
|
| Name |
Silphion Research Private Limited |
| Address |
44, 1st Main Rd, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrRagavi |
RENDER skin and hair |
7th floor, Department of dermatology and cosmetology, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU |
7708716948
drragavi@renderclinic.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RENDER SKIN AND HAIR,Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Xerosis, Dry skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Smoo Buttergel and Smoo Baby Lotion |
Smoo Buttergel, Smoo Baby Lotion, and two reference products are applied (50 mg over 25 sq cm), with hydration measured at 10 minutes, 1 hour, 4 hours, 6 hours, and 24 hours post-application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Not on medication or medical care for 1 month before and during the study
2. Free from dermatological/systemic disorders affecting results
3. Available for the entire study duration
4. Provided written informed consent
5. Abstained from using soaps/moisturisers on test area for 1 week before and during study |
|
| ExclusionCriteria |
| Details |
1. Known sensitivity to cosmetics/moisturisers
2. Diagnosed with chronic skin allergies
3. Excessive hair on test sites
4. Pregnant or nursing women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in hydration level and duration of effect by each moisturiser using DermaLab Combo Hydration Probe |
10 minutes, 1 hour, 4 hours, 6 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Product safety, effectiveness, and tolerability |
10 minutes, 1 hour, 4 hours, 6 hours, 24 hours |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="4"
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 - NO
|
|
Brief Summary
|
This study aims to provide valuable insights into the effectiveness, safety, and tolerability of plant-based moisturizers, with the goal of promoting more informed and healthier skincare choices. The main evaluation focus is the improvement in skin hydration and the duration of moisture retention after product application. Additional assessment parameters include product safety, user acceptability, and overall skin compatibility. The study evaluates two plant-based moisturizers, namely Smoo Buttergel and Smoo Baby Pure Moisturizing Lotion, against two well-known market reference products using biophysical measurement tools. Skin hydration is assessed using the DermaLab Combo Hydration Pin Probe, which measures skin conductance to reflect moisture levels. Each product is applied at 50 mg per 25 sq cm area, and hydration levels are recorded at multiple time points up to 24 hours post-application. This structured protocol allows for objective comparison of hydration performance across products. The findings are expected to enhance understanding of how plant-based moisturizers perform in comparison to conventional products, potentially benefiting public health by encouraging the use of gentler, more natural formulations. |