| CTRI Number |
CTRI/2022/06/043046 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate safety of a test product for skin irritation |
|
Scientific Title of Study
|
Evaluation of Skin Safety of a test product Minoxidil 10%w/v and Finasteride 0.1%w/v
Topical Solution 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/017/0422/STU Version No.: 1 of 28 th April 2022 |
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 |
C Wing, Room No: 103, 1st Floor, Shiv Krupa, S.R.A. CHS Ltd, Panam Park, Off Sahar Road, Vile Parle East, Mumbai 400 057
Mumbai
MAHARASHTRA
400 057
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&D Centre, L.B.S. Marg
Vikhroli (W)
Mumbai
MAHARASHTRA
400 083
India |
| Phone |
9819596674 |
| Fax |
|
| Email |
trupti.chitre@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Trupti Chitre |
| Designation |
Director-Formulation Development |
| Affiliation |
Cipla Ltd. |
| Address |
R&D Centre, L.B.S. Marg
Vikhroli (W)
Mumbai
MAHARASHTRA
400 083
India |
| Phone |
9819596674 |
| 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. |
C Wing, Room No: 103, 1st Floor,Shiv Krupa, S.R.A. CHS Ltd, 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 committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with healthy skin conditions to be included in the trial |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% Sodium Lauryl Sulphate (Positive control) |
Single Patch Application 0.04 ml will be applied and will be occluded for 24 hours |
| Comparator Agent |
Isotonic Saline (Negative control) |
Single Patch Application 0.04 ml will be applied and will be occluded for 24 hours |
| Intervention |
Minoxidil 10%w/v and Finasteride
0.1%w/v Topical Solution. |
Filter papers dipped in test product (to contain approximately 0.04ml solution) will be filled in
wells of patch chambers and applied on back/upper arm of participant and occluded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Voluntary men and women between 18 and 60 years.
2.Photo type III to V.
Having apparently healthy skin on test area.
3.For whom the Investigator considers that the compliance will be correct.
4. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
5.Having signed a Consent Form.
6. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the study.
7. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna…), during the course of the study.
8 Should be able to read and write (in English, Hindi or local language).
9. 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 skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale. |
Induction Phase:
- Patch application on Visit V1, V3, V5, V7, V9, V11, V13, V15 and V17.
- Patch removal on Visit 2 (V2, V4, V6, V8, V10, V12, V14, V16 and V18).
- Scoring on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19)
Rest Phase: 10 – 14 days
Challenge Phase: Patch application will be on naïve sites on the arm/back on V20; patch will be removed at V21 (24 hours). Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2022 |
| Date of Study Completion (India) |
25/06/2022 |
| 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 Patch test is performed to assess the dermal safety of test product involved in the study. It is a technique used to determine the potential of specific substances to cause irritancy of the skin. In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed and the marked site is scored post 24 hours after the
removal of the patches. Reactions such as erythema, dryness and wrinkling are scored on a 0– 4-point scale and oedema is scored on another 0 – 4-point scale (Draize scale).
52 Healthy Men and Women will be included in this study and the irritancy of the test product will be assessed. Result: The study was completed with 52 complete cases and no adverse events. |