| CTRI Number |
CTRI/2024/12/078196 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the skin safety of topical products by Primary Irritation Patch test in Healthy Human Volunteers of all skin types. |
|
Scientific Title of Study
|
Evaluation Of Dermatological Safety Of Test Products By Primary Irritation 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/087 A |
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 |
9448075762 |
| 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
Bangalore
KARNATAKA
560083
India |
| Phone |
9448075762 |
| 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
|
| University of Pretoria
Plant Sciences Complex, Office 3-39
Medicinal Plant Science (Department of Plant and Soil Science) Pretoria 0002, South Africa |
|
|
Primary Sponsor
|
| Name |
University of Pretoria |
| Address |
Plant Sciences Complex, Office 3-39 Medicinal Plant Science (Department of Plant and Soil Science) Pretoria 0002, South Africa. |
| Type of Sponsor |
Research institution |
|
|
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 B |
TrialGuna Private Limited |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
09448075762
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 Volunteers of All Skin Types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Negative Control
2.Positive Control |
1.Negative Control-0.9% Isotonic Saline
Dose-0.04ml
Route of administration- Topical application
Total duration of such intervention- 1day
2.Positive Control-Sodium Lauryl Sulphate
Dose-0.04ml
Route of administration- Topical application
Total duration of such intervention- 1day
|
| Intervention |
Aloe wound cream |
1.Aloe Wound cream
Aloe Arborescens Miller extract-05.00 %
Tea Tree Essential Oil-02.00%
Lavender Essential Oil-00.30%
Rose Hydrosol-10.20%
Distilled Water -64.70%
Dimethicone-05.00%
Cyclomethicone-05.00%
Saliguard BDHAb- 00.80%
Ceramide 3 -04.00
Polyacrylate Crosspolymer-6-03.00 %
2.Placebo Wound cream
Tea Tree Essential Oil-02.00%
Lavender Essential Oil-00.30%
Rose Hydrosol-10.20%
Distilled Water-69.70%
Dimethicone-05.00%
Cyclomethicone -05.00%
Saliguard BDHA b -00.80 %
Ceramide 3 -04.00%
Polyacrylate Crosspolymer-6 -
03.00 %
Dose frequency- 0.04g
Route of administration- Topical application
Total Duration of such intervention- 1 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 (e.g. swimming) or activity which causes excessive sweating (e.g. exercise, sauna) 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 (Appendix IV).
|
|
| 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 (presently or in the past 1 month).
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 2 Day 3 and Day 9 |
|
|
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)= "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)
|
27/12/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The objective of the study is to assess the dermatological safety of the test products on healthy human subjects. This will be an open-label, non-randomized, monocentric, single-application, controlled clinical trial. Healthy adult volunteers will be selected according to specific inclusion and exclusion criteria. A total of 24 healthy adult participants, both male and female, aged between 18 and 65 years in a 1:1 ratio, will be tested with the test products intended for use on normal skin. The patch application will be evaluated based on the assessment criteria outlined in the appendices. References Related to Background of the Trial from Bureau of Indian Standards (BIS)- Methods of Test for Safety Evaluation of Cosmetics (IS 4011:2018), Third Revision |