| CTRI Number |
CTRI/2011/11/002113 [Registered on: 09/11/2011] Trial Registered Retrospectively |
| Last Modified On: |
26/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmoceutical] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Dermatological safety of the investigational products by applying patch on the upper back of 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 |
| NIL |
NIL |
|
|
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,Karnataka,India
Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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,Karnataka,India
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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,Karnataka,India
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICHIMARU PHARCOS CO Ltd |
| Address |
318-1 Asagi, Motosu- Shi, Gifu 501-0475, Japan |
| Type of Sponsor |
Other [Cosmoceutical Company] |
|
|
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 |
Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore-560025, Karnataka, India
Bangalore
KARNATAKA |
918040917253
918041125934
mukta.sachdev@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Aditya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male & female volunteers with no Skin Allergy /Infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Acne buster lotion 10% |
Acne buster is a mixture of cosmetic ingredients and each ingredient has safety certificate of ingredient. |
| Intervention |
Acne buster 3% |
(lower concentration of above one)
Acne buster is a mixture of cosmetic ingredients and each ingredient has safety certificate of ingredient.
|
| Intervention |
Malpe SAP extract |
Maple sap is collected by tapping the Maple Trees and Maple Sugar and Maple syrup used for food is made from Maple Sap. We would like to use maple sap as cosmetic ingredient. Below is the composition of Maple Sap. |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ponkan extract |
This product is a extract of Mandarin Orange in 1-3 Buthylene Glycol (70%). This fruits is a generally consumed product and safety for human. Buthylene Glycol is commonly used solvent for cosmetic products all over the world. |
| Intervention |
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. |
| Intervention |
Wild Thyme extract |
This plant is extracted by using 50% 1-3 Butylene Glycol. So the composition of extract is;
1-3 Butylene Glycol 50%, water 49.1%, plant extract 0.9%. Since the majority of the extract is Butylene glycol and water. So, we assume that there will not be any adverse effects on skin.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with skin type III to V.
2)Subjects willing to give a written informed consent.
3)Subjects willing to maintain the patch test in position for 24 hours
4)Subject has not participated in a similar investigation in the past two weeks.
5)Subjects willing to come for regular follow up.
6)Subjects ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
1)Infection, allergy on the tested area
2)History of skin allergy antecedents or atopic subjects
3)History of hyper sensitivity to any component of the tested products
4)Athletes and subjects with history of excessive sweating
5)Cutaneous disease which may influence the study result
6)Chronic illness which may influence the cutaneous state.
7)Subjects on oral corticosteroid with dose >10mg/day
8)Subjects participating in any other cosmetic or therapeutic trial.
9)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. |
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To gather safety information prior to a pilot study and/or larger study, in order to improve the latter’s quality and efficiency of the study design. |
Dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application. |
|
|
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)
|
07/11/2011 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective:To evaluate the dermatological safety of the given investigational
product/s on skin of healthy human volunteers by primary irritation patch test
Subject Population: 24 Healthy Human Volunteers (Male and Female).
Duration of Study: 5 Visits (9 Days for each volunteer)
Inclusion Criteria:1.
Subjects age group 18 - 55 years
2.
Healthy male & female volunteers
3.
Subjects with skin type III to V.
4.
Subjects willing to give a written informed consent.
5.
Subjects willing to maintain the patch test in position
for 24 hours
6. Subject
has not participated in a similar investigation in the past two weeks.
7.
Subjects willing to come for regular follow up.
8.
Subjects ready to follow instructions during the study
period.
1.
Infection, allergy on the tested
area
2.
History of skin allergy
antecedents or atopic subjects
3.
History of hyper sensitivity to
any component of the tested products
4.
Athletes and subjects with history of excessive sweating
5.
Cutaneous disease which may
influence the study result
6.
Chronic illness which
may influence the cutaneous state.
7.
Subjects on oral corticosteroid with dose >10mg/day
8.
Subjects participating in any
other cosmetic or therapeutic trial. Exclusion Criteria:
1.
Infection, allergy on the tested
area
2.
History of skin allergy
antecedents or atopic subjects
3.
History of hyper sensitivity to
any component of the tested products
4.
Athletes and subjects with history of excessive sweating
5.
Cutaneous disease which may
influence the study result
6.
Chronic illness which
may influence the cutaneous state.
7.
Subjects on oral corticosteroid with dose >10mg/day
8.
Subjects participating in any
other cosmetic or therapeutic trial.
9.
Any history of underlying
uncontrolled medical illness including diabetes, liver disease or history of
alcoholism, HIV or any other serious medical illness.
|