| CTRI Number |
CTRI/2024/08/072683 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study safety of test product in humans. |
|
Scientific Title of Study
|
Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/046/0624/STU. Version No.: 1 of 16th July 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Cheryl Laboratories Pvt.Ltd
Persian Apartment, Plot No, 434, Ground floor,
V.P. Road, Andheri (W) Mumbai-400058 |
|
|
Primary Sponsor
|
| Name |
Cheryl Laboratories Pvt.Ltd |
| Address |
Persian Apartment, Plot No, 434, Ground floor,
V.P. Road, Andheri (W) Mumbai-400058 |
| 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 Rajiv Joshi |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
Room No: 103, 1st Floor, C Wing, Shiv Krupa, S.R.A. CHS Ltd, Panam
Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLAIMS 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 will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Minoxidil + Procapil Solution (Ethanol base) |
Filter papers dipped in liquid test products (to contain approximately 0.04 ml
of test product) will be applied once on upper arm/back of participant and semi-occluded with the help of gauze. Duration of occlusion will be 24 hours. |
| Intervention |
5% Minoxidil + 0.1%
Finasteride + Procapil Solution
(Ethanol base) |
Filter papers dipped in liquid test products (to contain approximately 0.04 ml of test product) will be applied once on upper arm/back of participant and semi-occluded with the help of gauze. Duration of occlusion will be 24 hours. |
| Comparator Agent |
Negative control -0.9% Isotonic saline solution |
Filter papers will be dipped in negative control -0.9% Isotonic saline solution (to contain approximately 0.04ml of solutions) will be filled in different wells of Patch chambers and will be applied occlusively once on upper arm/back of each participant. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Comparator Agent |
Positive control -1% Sodium Lauryl Sulphate |
Filter papers will be dipped in positive control -1% Sodium Lauryl Sulphate solution (to contain approximately 0.04ml of solutions) will be filled in different wells of Patch chambers and will be applied occlusively once on upper arm/back of each participant. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
|
|
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 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 using
Draize scale. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
10/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This 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. Irritants are substances that damage the skin by direct toxic action. The damage will depend upon the nature of the irritant, its concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), vesiculation and finally to an intense suppurative reaction without the involvement of immune system. In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed under a constant artificial daylight source 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)
Result: The study was completed with 26 complete cases and no adverse events were reported. |