| CTRI Number |
CTRI/2025/05/087333 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the safety of test product on skin in men and women. |
|
Scientific Title of Study
|
Evaluation of Skin Safety of a Test Product for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/015/0425/STU Version No.: 1 of 22nd April 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator - Consultant Dermatologist |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
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 |
Dr Sagar Katare |
| Designation |
Head - Clinical Research |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Medical affairs, Clinical research, 2nd floor, 7-1-27, Ameerpet
Hyderabad
TELANGANA
500016
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.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 |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories Ltd., 7-1-27, Ameerpet
Hyderabad 500016, India |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet
Hyderabad 500016, India |
| 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, , Panom 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 |
| 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 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 - 3% Sodium Lauryl Sulphate |
Filter papers will be dipped in positive control -3% 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 on upper arm/back of each participant. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Intervention |
Venusia Cleanser |
Test product will be diluted to 8%w/w in Distilled water. Filter papers
dipped in diluted product (to contain approximately 0.04 ml of solution) will be filled in different wells of Patch chambers and will be applied occlusively on upper arm/back of each participant for a duration of 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 with 50 % having sensitive skin as determined by lactic acid sting test@.
2. Fitzpatrick skin 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. Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna...), during the course of the trial.
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. Athletes and participants with history of sweating.
3. Scars, excessive terminal hair, or tattoo on the studied area.
4. A participant who the Investigator feels will not be compliant with trial requirements
5. Dermatological infection/pathology on the level of studied area.
6. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
7. Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
8. Chronic illness which may influence the outcome of the trial.
9. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
10. 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. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
26/05/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patch test - This test is performed to assess the dermal safety of test products 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 to 4-point scale and oedema is scored on another 0 to 4-point scale (Draize scale) |