| CTRI Number |
CTRI/2025/12/099827 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the safety of the test product after applying it on skin in men and women. |
|
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/161/1225/STU Version No.: 1 of 13th December 2025 |
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 |
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 |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
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 |
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
|
| Om Sai Pharma Pack
Plot No. 38 & 39, Sector -11, Siidcul, I.I.E.,Haridwar, Uttarakhand – 249403 |
|
|
Primary Sponsor
|
| Name |
Om Sai Pharma Pack |
| Address |
Plot No. 38 & 39, Sector -11, Siidcul, I.I.E.,
Haridwar, Uttarakhand – 249403 |
| Type of Sponsor |
Other [Contract Development and Manufacturing Organization] |
|
|
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 |
| Intervention |
Clindamycin and Tretinoin
(Microsphere) Silicone base gel |
Approximately 0.04 gm of test product will be filled in wells of patch chamber and applied on back/upper arm of participant. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Comparator Agent |
Negative control - 0.9% Isotonic saline |
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 of participant. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Comparator Agent |
Positive control - 1% w/w SLS solution |
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 of participant. Then it will be occluded. 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 that 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). |
|
|
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="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)
|
12/01/2026 |
| Date of Study Completion (India) |
23/01/2026 |
| 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)
|
Patch test - 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 as per protocol with 52 complete cases. |