| CTRI Number |
CTRI/2025/05/087970 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Testing Skin Irritation Using Patch Test in Healthy Adults |
|
Scientific Title of Study
|
Evaluation of Dermatological safety of Test Products by Primary Irritation Patch Test on Healthy Human Volunteers of All Skin Types |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/PRO/25/COS/002, Version 1.0, 16APR2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohandas Shetty B |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block
Bangalore
KARNATAKA
560083
India |
| Phone |
9448075762 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sohandas Shetty B |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block
Bangalore
KARNATAKA
560083
India |
| Phone |
9448075762 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CEO and Founder |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Vasu Healthcare Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Vasu Healthcare Pvt. Ltd. |
| Address |
967/4, Makapura GIDC, Makapura, Vadodara, Gujarat
390010 |
| 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 Nimisha Sivanandan |
TrialGuna Private Limited |
Room No 01, First floor,
#467, 1st Main, 4th Cross, Royal County layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA |
9952088650
nimisha.sivanandan@trialguna.com |
|
|
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 individual with normal, dry, oily and combination skin type |
|
|
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- 1 day
2. Positive Control - Sodium Lauryl Sulphate Dose - 0.04ml Route of administration - Topical application total duration of such intervention- 1 day |
| Intervention |
Trichup Pro Hair Mask |
1. Stearyl Alcohol
2. Cetyl Alcohol
3. Cetrimonium Chloride
4. Behentrimonium Chloride
5. Glycerin
6. Bis-Cetearyl Amodimethicone
7. Cocodimonium Hydroxypropyl Hydrolyzed Wheat Protein
8. Hydrolyzed Soy Protein Extract
9. Acrylamidopropyltrimonium Chloride/ Acrylamide Copolymer
10. Disodium EDTA
11. Polyquaternium-10
12. Water (72.9%) (and) Magnesium nitrate (21%) (and) Methylchloroisothiazolinone (1.2%) (and) Magnesium chloride (4.5%) (and) Methylisothiazolinone (0.4%)
13. Isoamyl Laurate
14. Cetyl Palmitate
15. Bis-Diisopropanolamino-PG-Propyl Disiloxane/ Bis-Vinyl Dimethicone Copolymer
16. Isopropyl Myristate
17. Candelilla Wax
18. Hydroxyethyl cellulose
19. Citric Acid
20. Parfum
21. Aqua
|
| Intervention |
Trichup Pro Hair Serum |
1. Cyclopentasiloxane (85%) (and) Dimethiconol (15%)
2. Triticum Vulgare Germ Oil
3.Olea Europaea Fruit Oil
4. BHT
5. Bis-Diisopropanolamino- PG-Propyl Disiloxane/Bis-Vinyl Dimethicone Copolymer
6. Parfum
7. Cyclopentasiloxane
|
| Intervention |
Trichup Pro Scalp Nourishing Hair Oil |
1. Helianthus Annuus Seed Oil
2. BHT
3.Ocimum basilicum Oil
4. Citrus medica acida peel Oil
5. Melaleuca alternifolia leaf Oil
6. Tocopherol
7. Mentba Piperita Oil
8. Prunus amygdalus sativa kernel Oil
9.Persea Gratissima Oil
10.Rosmarinus officinalis flower Oil
11. Squalane
|
| Intervention |
Trichup Pro Shampoo |
1. Sodium Laureth Sulfate
2.Cocamidopropyl Betaine
3. Water (44%) (and) Dimethiconol (55%) and TEA-Dodecylbenzenesulfonate (1%)
4. Glycerin
5.Olive Oil PEG-7 Esters
6.Water (35%) (and) Coco-Glucoside (30%) (and) Glyceryl Oleate (30%) (and) Citric Acid (5%)
7.Dimethicone
8.Glycol Di stearate
9.Sodium Cocoyl Glycinate
10.Cocodimonium Hydroxypropyl Hydrolyzed Wheat Protein
11. Hydrolyzed Soy Protein Extract
12. Guar Hydroxypropyltrimonium Chloride
13. Cocamide DEA
14. Disodium EDTA
15. Water (72.9%) (and) Magnesium nitrate (21%) (and) Methylchloroisothiazolinone (1.2%) (and) Magnesium chloride (4.5%) (and) Methylisothiazolinone (0.4%)
16. PEG 45-M
17. Bis-Diisopropanolamino-PG-Propyl Disiloxane/ Bis-Vinyl Dimethicone Copolymer
18. Sodium Chloride
19. Citric Acid
20. Sodium Hydroxide
21. Parfum
22. Aqua |
|
|
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 apparently healthy skin in 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. The subject is informed of the need and duration of the examination and is ready to comply with protocol requirements.
6. Subject is ready to sign the informed consent form.
7. Subjects’ willingness to avoid intense UV exposure on test sites (sun or artificial UV) during the study.
8. Subjects’ 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 Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).
|
|
| ExclusionCriteria |
| Details |
1. Pregnant/nursing mothers.
2. Scars, acne, excessive terminal hair, or tattoos on the studied area.
3. Dermatological infection/pathology on level of studied area.
4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change from irritation potential of the test products from baseline to post application measured using the mean irritation score.
2. Score of less than or equal to 2 on the Draize scale.
|
Day 2, Day 3 and Day 9 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of treatment-emergent adverse events (safety and tolerability) |
Day 2, Day 3 and Day 9 |
|
|
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)
|
10/06/2025 |
| 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="0"
Months="3"
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
|
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 for irritancy of the test products intended for use on normal skin. The patch application will be evaluated based on the assessment criteria outlined in the appendices.
The patch test will be carried out according to the protocol study design, Declaration of Helsinki, GCP, BIS guidelines (IS 4011:2018 Third Revision, July 2018 guidelines), ICMR guidelines and New Drugs and Clinical Trials Rules. |