| CTRI Number |
CTRI/2021/07/035262 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Patch test |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety testing of cosmetic product using Patch Test |
|
Scientific Title of Study
|
Evaluation of dermatological safety and adverse reaction of Entice Glow Moisturizer for dermatological safety by 24 hrs patch test under complete occlusion on healthy human subjects.. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCS/ PT/001/2021 Version no 1.0 dated 17th June 2021June |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMadan Mohan |
| Designation |
Principal investigator -Professor and HOD Dermatology department |
| Affiliation |
Dr. B.R. Ambedkar Medical College Hospital |
| Address |
Sigma Skin & Cosmetology Clinic
No 609, 10th cross road, 7th Block ,Jayanagar,
Bengaluru, Karnataka-560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
drmadan1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MsSushmithaS |
| Designation |
Director |
| Affiliation |
Entice Supplements Pvt Ltd |
| Address |
Ashirvad Complex, No. B.F.F-1, 1st Floor, Building No. 104,
8th Cross, East Park Road, Malleshwaram, Bangalore - 560003
Bangalore
KARNATAKA
560003
India |
| Phone |
|
| Fax |
|
| Email |
sushmitha.gowda9425@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MsSushmithaS |
| Designation |
Director |
| Affiliation |
Entice Supplements Pvt Ltd |
| Address |
Ashirvad Complex, No. B.F.F-1, 1st Floor, Building No. 104,
8th Cross, East Park Road, Malleshwaram, Bangalore - 560003
KARNATAKA
560003
India |
| Phone |
|
| Fax |
|
| Email |
sushmitha.gowda9425@gmail.com |
|
|
Source of Monetary or Material Support
|
| Entice Supplements Pvt Ltd Ashirvad Complex, No. B.F.F-1, 1st Floor, Building No. 104, 8th Cross,East Park Road, Malleshwaram, Bangalore - 560003 |
|
|
Primary Sponsor
|
| Name |
Entice Supplements Pvt Ltd |
| Address |
Ashirvad Complex, No. B.F.F-1, 1st Floor, Building No. 104, 8th Cross,East Park Road, Malleshwaram, Bangalore - 560003 |
| Type of Sponsor |
Other [Nutraceutical supplement company ] |
|
|
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 |
| DrMadan Mohan N T |
Sigma Skin & Cosmetology Clinic |
No 609, 10th cross road, Ground floor room number 1 7th Block ,Jayanagar,
Bengaluru, Karnataka-560070
Bangalore
KARNATAKA |
9845074316
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospitals Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin irritation test |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Entice Glow Moisturizer |
Dose : 500mg
Frequency: once daily
Duration : 24 hrs
The product is applied to the volunteer by patch using IQ chambers. |
| Comparator Agent |
NIL |
NIL |
|
|
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 (both the ages inclusive).
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 one month.
7. Subjects willing to come for regular follow up visits.
8. Subjects ready to follow instructions during the study period.
Test period: 9 days for all subjects including screening day.
|
|
| ExclusionCriteria |
| Details |
1. Infection, allergy on the tested area.
2. Skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Cutaneous disease which may influence the study result.
5. Subjects on oral corticosteroid .
6. Subjects participating in any other cosmetic or therapeutic study.
7. 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse event monitoring |
0 hr to 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The patch test is the most common technique to evaluate a product tolerance on human skin. There are various methods of patch test which differ on the study objectives. The most common method is single application occlusive patch test for 24 hrs followed by observation after 48 hrs after application also. This method is a very common method in dermatological & inhalation practice to evaluate any intolerance which can result in acute dermatitis. The current study objective is
evaluation of dermatological safety and adverse reaction of Entice Glow
Moisturizer for dermatological safety by 24 hrs patch test under complete
occlusion on healthy human subjects.
|