| CTRI Number |
CTRI/2025/12/098293 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
Study to test safety of skin care product on skin in humans |
|
Scientific Title of Study
|
Evaluation of the Irritation Potential of Skincare Formulation (Anaboom Stem Serum) on Sensitive Skin in Healthy Human Subjects through Patch Test Method. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q13-SN-AT25; Version: 01; Dated: 14/11/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd. Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
| 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 Mohit Lalvani |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
mohit.CTRI@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with sensitive skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anaboom Stem Serum |
Patch application as per BIS standard. A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will be kept as is for 24 hours and removed after that. |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
A single application of about 0.04ml of 0.9% Isotonic Saline, is applied under occlusion for 24 hrs on the subjects back. The patch will be kept as is for 24 hours and removed after that. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
A single application of about 0.04ml of 1% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. The patch will be kept as is for 24 hours and removed after that. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Female and male Asian Indian subjects with phototype III-V.
2)Healthy human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)
3)Between 18 and 65 years of age.
4)Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar)
5)Subjects representing sensitive skin type (as per the Baumann’s questionnaire answered by subjects) |
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2)Having eczema, psoriasis, lichen planus, vitiligo at the test site of analysis.
3)Having disorder of the healing at the test site of analysis
4)Having rhinitis, allergic conjunctivitis or rhino sinusitis
5)Having hypersensitivity/ allergy to any cosmetics, perfumes and/or conservatives in cosmetic products, etc.
6)Having an allergy to plaster
7)Having a food allergy
8)Having scar excessive terminal hair or tattoo on studied area
9)Having a cardiovascular pathology (taking a beta blocker treatment)
10)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
11)Taking a retinoid-based treatment by general or oral route
12)Taking specific treatment on the back.
13)Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
14)Having miliaria (prickly heat) on the back.
15)Presenting too many naevus on the back
16)Having high pilosity on the back.
17)Refusing to follow the restrictions below during the study:During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back, Till the follow up period of until T8 days, only use of water is acceptable from the first reading i.e., T2 days (24 hours after the patch removal), Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches), Do not expose the back to the sun. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean score calculation for assessment of irritation potential (i.e., erythema, scaling, dryness wrinkling & oedema) |
24 hours after the patch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events (AEs) and serious adverse events (SAEs) reported by the subject and the dermatologist, throughout the study |
Baseline, 24 hours after patch application, 24 hours after patch removal, week after patch removal |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
13/12/2025 |
| 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 evaluate the irritation potential of Anaboom Stem Serum on healthy individuals with sensitive skin. A total of 26 subjects (13 male and 13 female), aged between 18 and 65 years, will be enrolled to assess the product’s safety and tolerability through a single-application closed patch test. Dermatological assessment will be conducted using the Primary Irritation Patch Test method as per BIS Standard IS 4011:2018. |