| CTRI Number |
CTRI/2021/03/032023 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
28/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To test the safety of 3 test products for skin irritation |
|
Scientific Title of Study
|
Evaluation of Skin Safety of 3 topical formulations (Minoxidil 2%) for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans)
IS 4011:2018 Guidelines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/100/0121/STU Version No: 1 of 27th January 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Manish Sule |
| Designation |
Consultant / Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT. LTD (Clinical Aesthetics & Investigative Management Service) |
| Address |
4th Floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai-400058
Mumbai
MAHARASHTRA
400058
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
palkarpallavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyank Shah |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East),
Mumbai,
Mumbai
MAHARASHTRA
400063
India |
| Phone |
7030271166 |
| Fax |
|
| Email |
Priyank.Shah1@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Thavkar |
| Designation |
General Manager – Medical Affairs |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East),
Mumbai,
Mumbai
MAHARASHTRA
400063
India |
| Phone |
|
| Fax |
|
| Email |
Amit.Thavkar@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd.
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East),
Mumbai, Maharashtra (India) – 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East),
Mumbai, Maharashtra (India) – 400 063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pallavi Manish Sule |
C.L.A.I.M.S. PVT. LTD |
B / 4th floor, Modi House, C-10 Dalia Ind. Est., Off New Link Road, Andheri West, Mumbai-400058
Mumbai
MAHARASHTRA |
02266758851
palkarpallavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy skin on test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% Sodium Lauryl sulphate-Positive Control |
0.04 ml will be filled and occluded for 24 hours. One time application |
| Comparator Agent |
Isotonic Saline- Negative Control |
0.04 ml will be filled and occluded for 24 hours. One time application |
| Intervention |
Minopep Eva 2% |
0.04 ml will be filled and occluded for 24 hours. One time application |
| Intervention |
Minoxidil Topical Solution 2% |
0.04 ml will be filled and occluded for 24 hours.
One time application |
| Intervention |
Mintop 2% |
0.04 ml will be applied, kept unoccluded till it dries. Then it will be occluded for 24 hours.
One time application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Having apparently healthy skin on test area.
Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial. |
|
| ExclusionCriteria |
| Details |
Pregnancy (by history) and lactating women.
Scars, excessive terminal hair or tattoo on the studied area
Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of skin irritation reactions using Draize scale |
48 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2021 |
| Date of Study Completion (India) |
28/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The test products,
- Minoxidil
Topical Solution USP 2% (Sun Pharma) - B No.: 26202491SB006 - Minopep
Eva 2% Topical Solution - B No.: C20B018 - Mintop
2% Topical Solution - B No.: CT10016
were dermatologically tested and found to be “Non-Irritant†based on IS 4011:2018, Methods of Test for safety evaluation of
cosmetics - Third Revision. |