| CTRI Number |
CTRI/2013/01/003321 [Registered on: 23/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2013 |
| 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- Patch test |
|
Scientific Title of Study
|
Single application closed patch test to evaluate the safety of test formulations on healthy human subjects . |
| Trial Acronym |
PIPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/362, Version: 1.0, Dated: May 03,2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
KETs Scientific Research Centre. |
| Address |
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
KETs Scientific Research Centre. |
| Address |
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
KETs Scientific Research Centre. |
| Address |
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
KETs Scientific Research Centre.Cosmetology Division,
4th floor,V.G.Vaze College campus,Mithaghar Road,Mulund-(E) Mumbai(Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
meghana@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
| Wyeth Consumer Healthcare, Level 6 , Platina, Plot No C-59, G Block, Bandra urka Complex |
|
|
Primary Sponsor
|
| Name |
Wyeth Consumer Healthcare |
| Address |
Wyeth Consumer Healthcare
Level 6 , Platina, Plot No C-59, G Block, Bandra urka Complex, Bandra(East) , Mumbai 400098 |
| Type of Sponsor |
Other [Consumer Healthcare] |
|
|
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 |
| Ms Meghana Surve |
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
Mumbai (Suburban)
MAHARASHTRA |
02225639644
02221635404
meghana@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT SCIENTIFIC & ETHICS COMMITTEE, MUMBAI, |
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 |
| Comparator Agent |
(Experimental Comparator):Sodium Lauryl Sulphate 20% Solution |
Day 1 (day of patch application, removal and 0 hr observation), Day 2 (24 hrs.observation after Patch Removal),Day 3(48 hrs. observation after patch removal) and Day 4 (72 hrs observation after patch removal).
|
| Intervention |
1. Anne French Tender Care- with Wheat germ oil and Aloe cucumber perfume |
Day 1: (patch application, Removal and o hour observation), Day 2 (24 hrs.observation after Patch Removal),Day 3 (48 hrs. observation after patch removal) and Day 4 (72 hrs observation after patch removal).
|
| Intervention |
Anne French Tender Care- with Shea Butter and green tea perfume |
Day 1 (day of patch application, removal and o hr. observation), Day 2 (24 hrs.observation after Patch Removal), Day 3(48 hrs. observation after patch removal) and Day 4 (72 hrs observation after patch removal). |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Is a female in generally good health,Is between the ages of 14 and 18 years,Has not participated in a similar clinical investigation in the past four weeks,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,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Irritation potential |
On each subject’s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigational products to be tested for irritancy test |
On each subject’s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs
|
|
|
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)
|
15/05/2012 |
| 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="4" |
|
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. |