| CTRI Number |
CTRI/2012/11/003098 [Registered on: 09/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
31/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
To check irritation potential of the given samples |
|
Scientific Title of Study
|
Single application closed patch test to evaluate the safety of skin care formulations on healthy human subjects representing varied skin types. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/384,Version:01,Dated:October 08,2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MsMayuri Jaitpal |
| Designation |
Junior Scientist |
| Affiliation |
KETs Scientific Research Centre |
| Address |
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
mayuri@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MsMayuri Jaitpal |
| Designation |
Junior Scientist |
| Affiliation |
KETs Scientific Research Centre |
| Address |
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
mayuri@kelkarcosmetology.com |
|
Details of Contact Person
Public Query
|
| Name |
MsMayuri Jaitpal |
| Designation |
Junior Scientist |
| Affiliation |
KETs Scientific Research Centre |
| Address |
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze ColleCentre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
KETs Scientific Research Centre. V.G.Vaze College campus, Mithaghar Road, Mulund(E)
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
mayuri@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
| ITC R and D CENTRE Peenya Industrial Area, Peenya, Bangalore - 560058. Tel: 080 |
|
|
Primary Sponsor
|
| Name |
ITC R and D CENTRE |
| Address |
ITC R&D CENTRE
Peenya Industrial Area, Peenya, Bangalore - 560058.
Tel: 080 216303911
|
| Type of Sponsor |
Other [Cosmetics] |
|
|
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 |
| MsMayuri Jaitapl |
The KETs Scientific research centre, Cosmetology division |
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081
Mumbai (Suburban)
MAHARASHTRA |
02225639644
02221635404
mayuri@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT SCIENTIFIC & ETHICS COMMITTEE MUMBAI Applicable to PI Ms.Meghana Surve |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SKIN PATCH TEST |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Transparent Soap TSP 67-030 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
2.Transparent Soap TSP 67-032 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
3.Transparent Soap TSP 67-035 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
4.Opaque Soap TSP 70-42 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
5.Opaque Soap TSP 70-43 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Intervention |
6.Opaque Soap TSP 70-44 |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
| Comparator Agent |
Sodium Lauryl Sulphate 3% Solution |
Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Is a female/ male in generally good health?
2.Is between the ages of 18 and 50 years?
3.Has not participated in a similar clinical investigation in the past four weeks?
4.Is willing to give a written informed consent and come for regular observation?
|
|
| ExclusionCriteria |
| Details |
A known history or present condition of allergic response to any cosmetic products.
2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
3. Medications (e.g. steroids or antihistamines), which would compromise the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| irritation potential |
first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigational products to be tested for irritancy test |
On each subject’s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal). |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/10/2012 |
| 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="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
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
|
Skin Irritation Test: Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test. |