| CTRI Number |
CTRI/2017/05/008445 [Registered on: 02/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
cosmetic patch study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dermatology study in healthy human volunteers |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0005-17 Version 01 Date 25 Mar 17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Senthil kumar M B B S M D |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and Research Pvt Ltd |
| Address |
Spinos Life science and Research Pvt Ltd
Clinical trail unit
Door no 29 A
Krishna madura vanam Alankar thottam Vellakinar privu Thudiyalur Post Coimbatore
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Senthil kumar M B B S M D |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and Research Pvt Ltd |
| Address |
Spinos Life science and Research Pvt Ltd
Clinical trail unit
Door no 29 A
Krishna madura vanam Alankar thottam Vellakinar privu Thudiyalur Post Coimbatore
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Senthil kumar M B B S M D |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and Research Pvt Ltd |
| Address |
Spinos Life science and Research Pvt Ltd
Clinical trail unit
Door no 29 A
Krishna madura vanam Alankar thottam Vellakinar privu Thudiyalur Post Coimbatore
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| SpinoS Life Science and Research Pvt Ltd No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial area I Phase, Peenya Bangalore 560058 Karnataka India |
| Type of Sponsor |
Other [Cosmetic company] |
|
|
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 K Senthil Kumar |
SpinoS Life Science and Research Pvt Ltd |
No 29 A Clinical trails unit
Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India
Coimbatore
TAMIL NADU
Coimbatore
TAMIL NADU |
9994689336
senthilkumar.k@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE RAMANA Maharishi Rangammal Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patch test |
Applied 01 time and it remain 24 Hrs after that skin will be checked |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects in the age group of 18 - 55 years
2. Subjects with Fitzpatrick skin type III to V.
3. Subjects willing to give a voluntary written informed consent.
4. Subjects willing to maintain the patch test in position for 24 hours.
5. Subject having not participated in a similar investigation in the past two weeks.
6. Subjects willing to come for regular follow up visits.
7. Subjects ready to follow instructions during the study period.
8. Subjects without any open wounds, cuts, abrasions, irritation symptoms |
|
| ExclusionCriteria |
| Details |
1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.
2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.
3. Athletes and subjects with history of excessive sweating.
4. Subjects on oral corticosteroid.
5. Subjects participating in any other cosmetic or therapeutic trial.
6. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate dermatological safety |
Visit 01, 02, 03, 04 |
|
|
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)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2017 |
| Date of Study Completion (India) |
22/05/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. 10 test product will tested against 01 control with 24 subjects. total study duration is 10 days.
|