| CTRI Number |
CTRI/2024/07/071386 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Dermatological safety of Teat Product on Healthy Human Volunteers |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Product by Primary Irritant Patch
Test under 24 hrs occlusion on Healthy Human Volunteers of all skin types. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/088, Version 1.0, Dated 31 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
08867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
08867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Emami Limited, 13, Barrackpore Trunk Rd, Rathtala, Santhi Nagra Colony, Belghoria, Kolkata West Bengal - 700058 |
|
|
Primary Sponsor
|
| Name |
Emami Limited |
| Address |
13, Barrackpore Trunk Rd, Rathtala, Santhi Nagra Colony, Belghoria, Kolkata West Bengal - 700058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sohandas Shetty |
TrialGuna |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
08867125414
drsohanshetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FGL-ZANDU BALM |
Dosage: 0.04g, Route of Administration: Skin on back/upper arm, Treatment: Once a day. |
| Comparator Agent |
Negative Control: 0.9% Normal Saline |
Dosage: 0.9%, Route of Administration: Skin on back/upper arm, Treatment: Once a day. |
| Comparator Agent |
Positive Control: SLS Solution |
Dosage: 1% ww, Route of Administration: Skin on back/upper arm, Treatment: Once a day. |
| Intervention |
ZANDU ULTRA POWER BALM |
Dosage: 0.04g, Route of Administration: Skin on back/upper arm, Treatment: Once a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and women ratio of 1:1 between 18 and 65 years.
2. Having healthy skin on test area as assessed by dermatological examination.
3. For whom the investigator considers that the compliance will be correct.
4. Subjects with normal, dry, oily and combination skin in approximately equal ratio.
5. Subjects cooperating is informed of the need and duration of the examination and ready to comply with protocol procedures.
6. Having a signed consent form.
7. Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.
8. Willingness to avoid excessive water contact or activity which causes excessive sweating during the study.
9. Having valid proof of identity and age.
10. Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant/nursing mothers.
2. Scars, excessive terminal hair, or tattoo on the studied area.
3. Dermatological infection/pathology on level of studied area.
4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
6. Chronic illness which may influence the outcome of the study.
7. Subjects on any medical treatment either systemic or topical which may interfere with the
performance of the study treatment.
8. Subject 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 |
1. Number of subjects that showed no significant irritation.
2. Score of less than or equal to 2 on the Draize scale |
Day 1, Day 2, Day 3 & Day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
13/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
|
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
|
Clinical study will involve 24 healthy adult human subjects with Male & Female ratio of 1:1, will be tested FGL- ZANDU BALM and ZANDU ULTRA POWER BALM for pain. Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends upon the nature, concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), and vesiculation and finally, to an intense supportive reaction without the involvement of the immune system. In this patch test the irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs. |