| CTRI Number |
CTRI/2016/12/007615 [Registered on: 23/12/2016] 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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sapna R |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Reserch Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
8040917253 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur Lindia Limited |
| Address |
Dabur Research & Development Centre Dabur India Ltd Plot No.22, Site IV, Sahibabad,
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur Lindia Limited |
| Address |
Dabur Research & Development Centre Dabur India Ltd Plot No.22, Site IV, Sahibabad,
Ballia
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research & Development Centre Dabur India Ltd 22 Site IV Sahibabad Ghazibabd Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research & Development Centre Dabur India Ltd Plot No.22 Site IV Sahibabad Ghaziabad Uttar Pradesh India |
| Type of Sponsor |
Other [Healthcare & 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 Sapna R |
MS Clinical Research Pvt. Ltd, |
327/15, 1st Main Road
Cambridge Layout
Ulsoor Bangalore Karnataka
Bangalore
KARNATAKA |
8040917253
8040917253
sapna.r@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human normal skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Olive Badam Baby Massage Oil 2. Aloederm Cream 3. Skinetics Moist Lotion 4. Keratex 5.Femite 6. Keratone Oil |
Products were evaluated through single application closed patch test under occlusion for 24 hrs post patch removal. 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. |
| Comparator Agent |
3% Sodium Lauryl Sulphate |
3% Sodium Lauryl Sulphate solution in sterile water |
|
|
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 & 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 |
|
| ExclusionCriteria |
| Details |
1 Infection, allergy on the tested area
2 Skin allergy antecedents or atopic subjects
3 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
8 Subjects participating in any other cosmetic or therapeutic study.
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects. |
0 hr, 24 hr, 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall safety of Subjects |
0 hr, 24 hr, 7 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2014 |
| 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="17" |
|
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, and all the subjects completed the study. The study was conducted over a period of approximately 9 days for each subject. 40 micro litre of the test product was patched on the back of the subject under occlusion for 24 hrs. The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale.
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).3% SLS was used as positive control in the study was confirmed as irritant when observed at Ohr & 24hrs and was confirmed as mild irritant when observed at 7 days post patch removaL |