| CTRI Number |
CTRI/2017/08/009257 [Registered on: 03/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Skin Safety Study on Healthy Human Subjects |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/DAPT/2014-02, Version 1.0, March 03, 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd, |
| Address |
Mezzanine Floor, Classic Court, 9/1, Richmond Road,
Bangalore
KARNATAKA
560025
India |
| Phone |
9844020353 |
| Fax |
8041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd, |
| Address |
Mezzanine Floor, Classic Court, 9/1, Richmond Road,
Bangalore
KARNATAKA
560025
India |
| Phone |
9844020353 |
| Fax |
8041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research & Development Centre Dabur India Ltd Plot No.22,
Site IV, Sahibabad, Ghaziabad UP, India
Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Ltd.Dabur Research & Development Centre Dabur India Ltd Plot No.22, Site IV, Sahibabad,
Ghaziabad UTTAR PRADESH
201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Dabur Research & Development Centre Dabur India Ltd Plot No.22
Site IV Sahibabad Ghaziabad Uttar Pradesh India |
| Type of Sponsor |
Other [Other [Healthcare and FMCG]] |
|
|
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 Mukesh Ramnane |
MS Clinical Research Pvt. Ltd. |
327/15, 1st Main Road Cambridge Layout Ulsoor
Bangalore
KARNATAKA |
8040917253
8040917253
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM ETHICS COMMITTEE, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human with Sensitive Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% Sodium Lauryl Sulphate |
Sodium Lauryl Sulphate, diluted to a concentration of 3% w/W |
| Intervention |
Product 1- La! Tail
Product 2- Badam Tail Product 3- Shila X Tail Product 4- Mahanarayan Tail
Product 5- Maha Bhingraj Tail
Product 6- Rheumatil Gel
|
Study will be conducted over a period of 9 days for each subject.
Products will be evaluated through single application closed patch test under occlusion for 24 hrs. After patch removal, skin will be observed for irritation reactions at 0 hr, 24 hrs post patch removal for immediate reactions and 7 days post patch removal for delayed reactions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects in age group 18 -55 years
2 Healthy male and female subjects
3 Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks
7 Subjects willing to come for regular follow up visits
8 Subjects ready to follow instructions during the study period
9 Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same |
|
| ExclusionCriteria |
| Details |
•Infection, allergy on the tested area
•Skin allergy antecedents or atopic subjects
•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
•Subjects participating in any other cosmetic or therapeutic study.
•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
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type |
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type |
9 days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2014 |
| Date of Study Completion (India) |
28/05/2014 |
| 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
|
Result s of the study of this clinical Trial may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study was designed to test the safety of topical products provided by Dabur India Limited on healthy human subjects. 24 subjects were enrolled in the study, out of which all 24 subjects completed the study. Study was conducted over a period of 9 days for each subject. Products were evaluated through single application closed patch test under occlusion for 24 hrs. After patch removal, skin was observed for irritation reactions at 0 hr, 24 hrs post patch removal for immediate reactions and 7 days post patch removal for delayed reactions. As per Draize scale for scoring irritation, all the investigational products emerged as non irritant products when observed at Ohr, 24 hours and 7 days post patch removal All the test products were deemed to be dermatologically safe as per their classification into non irritant category at all time points of evaluation by 24 hrs occlusive patch test method (reference BIS 4011:1997).Positive control was confirmed as irritant when observed at Ohr & 24hrs and was confirmed as mild irritant when observed at 7 days post patch removaL |