| CTRI Number |
CTRI/2024/04/066320 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the skin irritation potential of Sawai fragrance |
|
Scientific Title of Study
|
A Clinical Study to evaluate the skin irritation potential of Sawai fragrance on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT184 Version 1.0 dated 13 Mar 2024 |
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 |
7078103723 |
| 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
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| SAWAI FRAGRANCES PVT LTD, SILVASSA |
|
|
Primary Sponsor
|
| Name |
SAWAI FRAGRANCES PVT LTD |
| Address |
Silvassa, Andheri East, Mumbai, Maharashtra, 400059 |
| 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 |
1st Floor room 3, Skin testing lab ,CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
7078103723
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. This is a Irritation Patch Test Study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finn chamber |
Each patch contains 0.04 ml of 1.Merve Red Royal Flush, 2.Merve Neon Moon, 3.Merve Barba Negra, 4.Merve Ballade Orientale, 5.Merve Le Grand Palais, 6.Merve Vibrant Leather, 7.Merve L’Emperur, 8.Merve Pacifico, 9.Merve Steller Oud, 10.Merve Abyss Oud, 11.Merve Blue Panther, 12.Merve Aube, 13.Merve Lumos, 14.Merve Supreme, 15.Merve Night Duke, 16.Merve Intense, 17.Merve Crimson, 18.Merve Ruby, 19.Merve Ambre, 20.Merve Medusa 21. Negative control(0.9% NaCl, 22. Positive Control- 1% SLS Route of Administration: Topical Frequency: Once Duration: 24 hours |
| 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. Photo type 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, Day 15 |
|
|
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)= "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)
|
06/05/2024 |
| 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="0"
Days="15" |
|
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
|
The below product would be tested as per the guideline IS4011 for dermal safety assessment.1.Merve Red Royal Flush 2.Merve Neon Moon 3.Merve Barba Negra 4.Merve Ballade Orientale 5.Merve Le Grand Palais 6.Merve Vibrant Leather 7.Merve L’Emperur 8.Merve Pacifico 9.Merve Steller Oud 10.Merve Abyss Oud, 11.Merve Blue Panther 12.Merve Aube 13.Merve Lumos 14.Merve Supreme 15.Merve Night Duke 16.Merve Intense 17.Merve Crimson 18.Merve Ruby 19.Merve Ambre 20.Merve Medusa The product will be tested for skin irritation on 24 healthy human volunteers. The study will carried out in an estimated 15 days. Assessment would be done on day 0, day 1, with followup visit on day 8 for erythema and Oedema scoring.
Study is done as per BIS standard 4011 |