| CTRI Number |
CTRI/2012/05/002648 [Registered on: 14/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Primary irritation patch test] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the safety of Investigational products by assessing the irritation after patch application on healthy human volunteers. |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/KSPT/2012-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd., |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court,
9/1 Richmond Road,Bangalore-560025
Karnataka,India.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd., |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court,
9/1 Richmond Road,Bangalore-560025
Karnataka,India.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd., |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court,
9/1 Richmond Road,Bangalore-560025
Karnataka,India.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kaya Skin Clinic |
| Address |
C-10, Dalia Industrial Estate,
Off Link Road, Andheri (W), Mumbai- 400058
Maharashtra, India
|
| Type of Sponsor |
Other [Cosmeceuticals] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt Ltd |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court,
9/1 Richmond Road,Bangalore,Karnataka,India.
Bangalore
KARNATAKA |
9180-40917253
9180-41125934
mukta.sachdev@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with varied skin type. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Daily Moisturising Sunscreen+.
2. Daily Use Sunscreen+.
3. Sensitive Sunscreen.
4. Post Laser Cream.
5. Antidandruff Hair Oil.
6. Nutrex Cream.
7. Code 10 Rave gel.
8. Code 10 Ice cooling gel.
9. Levant Wet look hair styling gel.
10. Levant Mega hold hair styling gel.
11. Levant ultra hold hair styling gel.
12. 2X1 cream gel.
13. Hair oil weak hair (VFM).
14. Hair oil damaged hair (VFM).
15. Hair oil dry hair (VFM).
16. Secret cream for hair fall control.
17. Secret cream for dry hair repair.
18. Secret cream for damaged hair.
19. Secret cream for weak hair repair.
20. Hair serum Malaysia ( Mayas).
21. Hair serum Malaysia ( original).
22. Wet look hair styling gel.
23. Insta brightening micro mask.
24. Hair oil hair fall (VFM).
|
All the products mentioned are used for cosmetic purpose.
Dose: 40 micro liter
Duration: the patch will be pasted for 24 hours and readings after 24 hr, 48 hr & on day 7 post patch application will be recorded.
Frequency: Patch will be pasted only once. |
| Comparator Agent |
Positive Control: Sodium Lauryl Sulphate solution |
Positive control Sodium Lauryl Sulphate solution:
40 µl of 3% solution of Sodium Lauryl Sulphate in distilled water (w/v) will be put on chambers prefixed on tape.
Dose: 40 micro liter
Duration: the patch will be pasted for 24 hours and readings after 24 hr, 48 hr & on day 7 post patch application will be recorded.
Frequency: Patch will be pasted only once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects age group 18 - 55 years.
Healthy male & female volunteers.
Subjects with skin type III to V.
Subjects willing to give a written informed consent.
Subjects willing to maintain the patch test in position for 24 hours.
Subject has not participated in a similar investigation in the past two weeks.
Subjects willing to come for regular follow up.
Subjects ready to follow instructions during the study period.
|
|
| ExclusionCriteria |
| Details |
Infection, allergy on the tested area
History of skin allergy antecedents or atopic subjects
History of hyper sensitivity to any component of the tested products
Athletes and subjects with history of excessive sweating
Cutaneous disease which may influence the study result
Chronic illness which may influence the cutaneous state.
Subjects on oral corticosteroid with dose >10mg/day
Subjects participating in any other cosmetic or therapeutic trial.
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
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test |
24 hours, 48 hours and 7 days post patch removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/04/2012 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is a primary irritation patch test under dermatological control. A patch test
under occlusion is carried out using IQ Chambers an inside area of 9X9mm (81mm2)
followed by assessment using Draize scale scoring. 24 healthy human volunteers will be enrolled into the study. Study duration is 9 days for each subject. The
required quantity of sample (as updated in the Investigational product manual)
will be put on chambers prefixed on tape.
This patch will then
be applied on the test site i.e. between the scapulae and waist of the
subjects. The patch will be kept for 24
hours. After which the patches will be removed and the first observation will
be made at 30 minutes of patch removal (24 hr reading). The further observations
will be at 48 hr and 7th day post patch application.
|