| CTRI Number |
CTRI/2013/07/003822 [Registered on: 19/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
09/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of a cosmetic/ayurvedic formulation in the treatment of Miliaria (Prickly Heat) |
|
Scientific Title of Study
|
An open label, single centered study to evaluate the efficacy of a cosmetic/ayurvedic formulation in the treatment of Miliaria (Prickly Heat) on affected children subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/404, Version: 01, Dated: April 12, 2013 |
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 |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
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 |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
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 |
The KET’s, Scientific Research Centre,Cosmetology Division, 4th Floor,V. G. Vaze College Campus,Mulund(E),Mumbai
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
02225639644 |
| Fax |
02221635404 |
| Email |
meghana@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHOLAYIL PVT LTD |
| Address |
31-A/24, SIDCO Industrial Estate - North, 4th Cross Main Road, Ambattur
CHENNAI - 600 098
|
| Type of Sponsor |
Research institution |
|
|
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 |
KETs Scientific Research Centre |
KETs Scientific Research Centre.V.G.Vaze College campus,Mithaghar Road, Mulund(E)
Mumbai (Suburban)
MAHARASHTRA |
02225639644
02221635404
meghana@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Scientific and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Miliaria (Prickly Heat), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline readings |
Baseline (day 1) |
| Intervention |
CPL/PHP/0213 |
Baseline (day 1), day 3 and
day 5.Sufficient quantity of the product shall be dusted on to cover the affected area properly.The product will be applied twice daily for a period of 5 days
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Volunteer in generally good health.
2.Volunteer between the ages of 05 to 12 years.
3.Volunteer with primary miliaria.
4.Volunteer has not participated in a similar clinical investigation in the past four weeks.
5.Volunteer willing to abstain from using any cosmetic/medical product on the test site during the entire study course.
6.Volunteer willing to visit the site on scheduled visit.
7.Volunteer willing to give a sign a written assent form and come for regular observation.
|
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of allergic response to any cosmetic products.
2.Skin disease except Miliaria (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings.
3.Medications (e.g. steroids or antihistamines), which would compromise the study.
4.Currently or has been undergoing dermatologist treatments or procedures within the last 1 month.
5.Volunteer viewed by the investigator as not being able to complete the study or participating in another study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the efficacy of the investigational product in reducing the miliaria. |
Baseline (day 1), day 3 and day 5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing irritation |
Baseline (day 1), day 3 and day 5. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/05/2013 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
This is an open label, single centered clinical study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label, single centered clinical
study. There will be only children (male and female) volunteers in the
study. Total 30 + 5 subjects will be enrolled in the study. This will be a 5
days study. All the subjects will be assessed on Baseline, day 3 and day 5. |