| CTRI Number |
CTRI/2025/10/096480 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical cream ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Check the Skin Safety of ‘Moisture IQ’ Cream in Healthy Adults Using a Patch Test |
|
Scientific Title of Study
|
Evaluation of Irritation Potential of MOISTURE IQ through Dermatological Evaluation by Single Occlusive Patch Test on Healthy Adult Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLC/19/25, Version: 1.0, Dated: 24.09.2025 |
Protocol Number |
| Secondary Id |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant |
| Affiliation |
DK Elite Health Care Centre |
| Address |
Room No 1, department of Pharmacology, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant |
| Affiliation |
DK Elite Health Care Centre |
| Address |
Room No 1, department of Pharmacology, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room no 1, Clinical trial department, No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai
Chennai
TAMIL NADU
600 044
India |
| Phone |
09003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Dermesse Raw and Naturals Private Limited., India |
|
|
Primary Sponsor
|
| Name |
Dermesse Raw and Naturals Private Limited., India |
| Address |
V35, V Block 14th Street Anna Nagar (Chennai) Chennai Tamil Nadu India 600040 |
| 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 |
| Dr Sakthi Balan |
DK Elite Health Care Centre |
DK Elite Health Care Centre,
First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY |
09843591097
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MOISTURE IQ |
Ingredients: Bees Wax, Shea Butter, Coconut oil, Magnesium Oil, Jojoba oil, Vitamin E oil.
study Duration: 8 days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy participants with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar)
2.Age group of 18 to 55 years, 12 male and 12 female participants.
3.Compliance with the study procedures involved. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Participants with any other skin disorders.
3.Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome
1. Erythema, dryness, wrinkles
Oedema
2. Mean Irritation Index
Scoring System (0-4):
0: No reaction
1: Very slight erythema/dryness/oedema
2: Slight erythema/dryness/oedema
3: Moderate erythema/dryness/oedema
4: Severe erythema/dryness/oedema
Evaluation Process:
3. Mean scores for erythema, dryness, wrinkles, and oedema will be
calculated for T1, T2, and T8 days using Microsoft Excel 2010 and
GraphPad Prism software.
4. Scores will be assessed for the test sample (Vanaura Organics
Products) and controls (including 1% sodium lauryl sulfate). |
T1 (0 Hours Post-Patch Removal)
T2 (24 Hours Post-Patch Removal)
T8 (1 Week Post-Patch Removal) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse event monitoring |
T1 (0 Hours Post-Patch Removal)
T2 (24 Hours Post-Patch Removal)
T8 (1 Week Post-Patch Removal) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
07/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
Inclusion Criteria:
Healthy volunteers with clear skin (no eczema, wounds, or scars) on the studied area. Age 18-55, with 12 male and 12 female volunteers. Full compliance with study procedures.
Exclusion Criteria:
Pregnant or lactating women. Volunteers with any skin disorders. Use of any topical agents on the application site within the past 30 days.
Methodology The study will involve 24 healthy adult volunteers (12 males and 12 females) aged 18-55 years, selected according to protocol guidelines. The procedure includes applying a patch containing Finn’s chamber on the back or shoulder area of the volunteers. Each chamber will hold 25 microlitres of the test product and one positive control. The patch will remain in contact with the skin for 24 hours. If any allergic reactions occur, the patch can be removed within 24 hours, and the investigator will be notified immediately. All procedures will be conducted as per the study protocol.
Examination Schedule Overview:
Screening: Registration, consent, health check, and dermatologist approval.
T0 (Pre-application): Acclimatization, patch application, AE/SAE monitoring.
T1 (0 hrs post-patch removal): Acclimatization, patch removal, AE/SAE monitoring.
T2 (24 hrs post-patch removal): Acclimatization, dermatological evaluation, AE/SAE monitoring.
T8 (1 week post-patch removal): Acclimatization, final dermatological evaluation, AE/SAE monitoring, and review of positive cases. |