| CTRI Number |
CTRI/2022/01/039409 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To test the safety of a test product in healthy human volunteers. |
|
Scientific Title of Study
|
Evaluation of Skin Safety of a test product Minoxidil 10 percent weight by volume and Finasteride
O.1 percent weight by volume Topical Solution for Primary Skin rrritation Using Skin Irritation Test (patch
Test in Humans)IS 4011:2018 Guidelines |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/052/0821/STU Version No.: 1 of 15th December 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT. LTD. |
| Address |
Shiv Krupa, S.R.A. CHS Ltd,
Panam Park, Off Sahar Road, Vile Parle East,
Mumbai
MAHARASHTRA
400057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Trupti Chitre |
| Designation |
Director Formulation development |
| Affiliation |
Cipla Ltd. |
| Address |
R and D Centre, LBS Marg, Vikhroli west
Mumbai
MAHARASHTRA
400083
India |
| Phone |
25761800 |
| Fax |
|
| Email |
trupti.chitre@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Trupti Chitre |
| Designation |
Principal Investigator |
| Affiliation |
Cipla Ltd. |
| Address |
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East,
Mumbai
MAHARASHTRA
400083
India |
| Phone |
25761800 |
| Fax |
|
| Email |
trupti.chitre@cipla.com |
|
|
Source of Monetary or Material Support
|
| CIPLA LTD.
R&D Centre, L.B.S. Marg
Vikhroli (W), Mumbai 400 083. |
|
|
Primary Sponsor
|
| Name |
CIPLA LTD |
| Address |
R&D Centre, L.B.S. Marg
Vikhroli (W), Mumbai 400 083. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Rajiv Joshi |
C.L.A.I.M.S. Pvt. Ltd. |
Shiv Krupa, S.R.A. CHS Ltd, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA |
02266758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteers with healthy skin will be included in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% isotonic saline solution - Negative control |
Filter papers dipped in negative control - 0.9% isotonic saline solution (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on test sites on back/upper arm. It will then be occluded for 24 hours. |
| Comparator Agent |
1% w/w SLS solution - Positive control |
Filter papers dipped in positive control -
1% w/w SLS solution (to contain approximately 0.04 ml of solutions) will be filled in different
wells of patch chambers and applied on test sites on back/ upper arm. It will then be occluded for 24 hours. |
| Intervention |
Minoxidil 10%w/v and
Finasteride 0.1%w/v Topical Solution |
Application zone: Skin on back/ upper arm
Filter papers dipped in test product (to contain approximately, 0.04ml) will be filled in wells of
patch test chambers and applied on back/upper arm of participant and occluded after drying |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and women (preferably equal number of males and females) between 18
and 65 years.
2. Photo type III to V.
3. Having apparently healthy skin on test area.
4. For whom the Investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the study.
8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna...), during the course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy (by history) and lactating women.
2. Scars, excessive terminal hair or tattoo on the studied area.
3. Dermatological infection/pathology on the level of studied area.
4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
5. Any clinically significant systemic or cutaneous disease, which may interfere with study
procedures.
6. Chronic illness which may influence the outcome of the study.
7. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the study (presently or in the past 1 month).
8. Participant in an exclusion period or participating in another food, cosmetic or therapeutic
trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of cutaneous tolerance by dermatological scoring of skin reactions (erythema,
oedema, dryness, scaling wrinkling) using Draize scale |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/01/2022 |
| Date of Study Completion (India) |
05/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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 product, Minoxidil 10%w/v and Finasteride 0.1%w/v Topical Solution B.No: 1204-085 was dermatologically tested and found to be “Non-Irritant†based on IS 4011:2018,Methods of Test for safety evaluation of cosmetics -Third Revision. |