| CTRI Number |
CTRI/2025/03/083154 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
skin saftey test of ASHP Personal Care Products |
|
Scientific Title of Study
|
A clinical study to evaluate the skin irritation potential of ASHP Multiple Personal Care Products on healthy human volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT553 Version 1.0 dated 06 Mar 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| ASHP VEDA PRIVATE LIMITED, Plot No. 01& 01-A, Parth Chiranjeevi Building, 2nd Floor, Hanuman Vatika, Gokulpura, Kalwar
Road, Jaipur-302012 |
| CCFT Laboratories, First floor, 135, Delhi Rd, besides Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh 250002 |
|
|
Primary Sponsor
|
| Name |
ASHP VEDA PRIVATE LIMITED |
| Address |
Plot No. 01& 01-A, Parth Chiranjeevi Building, 2nd Floor, Hanuman Vatika, Gokulpura, Kalwar
Road, Jaipur-302012 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
First Floor, 135, Panjabipura, Besides Ramleela Ground, Delhi Road Meerut
Meerut
UTTAR PRADESH |
9027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finn Chamber |
Each patch contains 40 microgram/ microliter of 1. Radiant Kashmiri Saffron And
Neem Body Wash, 2.Radiant Fruit Facial Scrub, 3. Skin Perfect Jasmine & Mogra
Day Cream, 4. Pure Skin Jasmine & Mogra
Body Lotion, 5. Radiant Kashmiri Saffron &
Neem Face Wash, 6.Essentials Of Shikakai &
Bhringraj Hair Conditioner , 7.Essentials Of Shikakai &
Bhringraj Hair Wash, 8. Essentials Of Japapatti &
Brahmi Hair Wash, 9. Essentials Of Japapatti &
Brahmi Hair Conditioner, 10.Skin Perfect Sandalwood &
Saffron Night Cream, 11. Skin Perfect Sunscreen Day
Cream Spf-25, 12. Exfoliating Narangi & Nagkesar
Body Ubtan Powder, 13. Nayaab Serum, 14.Nayaab Body Oil, 15.Nayaab Moisturising Face
Cream, 16.Goat Milk & Jojoba Oil Soap, 17. Saffron & Sandalwood Soap, 18. Sensuous Jasmine & Mogra
Soap, 19.Sandalwood & Turmeric Soap , 20.Hydrating Gulab Soap , 21. Ruh Khus Soap, 22.Organic Balck Color
Powder, 23.Organic Indigo Color Powder, 24. Organic Brown Color Powder, 25. Organic Heena Indigo Combo, 26. Anti Aging Serum, 27.Aloe Vera Gel, 28.Hair Elixir, 29.Acne Body Wash, 30. Negative control(0.9% NaCl, 31.Positive Control- 1% SLS) Route of Administration: Topical Frequency: Once Duration:24hrs |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary man or women between 18 and 65 years.
2. Phototype III to V.
3. Having apparently healthy skin on test area.
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
8. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the
course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
7.Chronic illness which may influence the outcome of the study.
8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Skin Irritation Score-erythema & oedema |
Day 0, Day 2 and Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The below products would be tested as per the guideline BIS4011 for dermal safety assessment.
1. Radiant Kashmiri Saffron And Neem Body Wash 2.Radiant Fruit Facial Scrub 3. Skin Perfect Jasmine & Mogra Day Cream 4. Pure Skin Jasmine & Mogra Body Lotion 5. Radiant Kashmiri Saffron & Neem Face Wash 6.Essentials Of Shikakai & Bhringraj Hair Conditioner 7.Essentials Of Shikakai & Bhringraj Hair Wash 8. Essentials Of Japapatti & Brahmi Hair Wash 9. Essentials Of Japapatti & Brahmi Hair Conditioner 10.Skin Perfect Sandalwood & Saffron Night Cream 11. Skin Perfect Sunscreen Day Cream Spf-25 12. Exfoliating Narangi & Nagkesar Body Ubtan Powder 13. Nayaab Serum 14.Nayaab Body Oil 15.Nayaab Moisturising Face Cream 16.Goat Milk & Jojoba Oil Soap 17. Saffron & Sandalwood Soap 18. Sensuous Jasmine & Mogra Soap 19.Sandalwood & Turmeric Soap 20.Hydrating Gulab Soap 21. Ruh Khus Soap 22.Organic Balck Color Powder 23.Organic Indigo Color Powder 24. Organic Brown Color Powder 25. Organic Heena Indigo Combo 26. Anti Aging Serum 27.Aloe Vera Gel 28.Hair Elixir 29.Acne Body Wash
The product will be tested for skin irritation on 24 human volunteers. Assessment would be done on day 0, day 3, with followup visit on day 8 for erythema and Oedema scoring |