| CTRI Number |
CTRI/2025/08/092145 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[Primary Irritation Patch Testing] |
| Study Design |
Other |
|
Public Title of Study
|
To assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects. |
|
Scientific Title of Study
|
Dermatological Safety Assessment of Test Products Using Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250037-SHL, Version 1.0, 12Jun24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Skin Harmony Lifescience Private Limited
Plot No. 1091/1 Flat No. 201, 2nd Floor, Opposite Srikara IIT and Medical Academy. Matrushri Nagar Colony Miyapur, Hyderabad, Telangana-500049 |
|
|
Primary Sponsor
|
| Name |
Skin Harmony Lifescience Private Limited |
| Address |
Plot No. 1091/1 Flat No. 201, 2nd Floor, Opposite Srikara IIT and Medical Academy. Matrushri Nagar Colony Miyapur, Hyderabad, Telangana-500049 |
| 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 Nayan Patel |
NovoBliss Research Private Limited |
Clinical Trial Department NovoBliss
Research Pvt. Ltd. Office 313,
Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
382481. Gandhinagar GUJARAT
382421 India Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adequate representation of varied skin types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANTI-ACNE FACE WASH
Salicylic acid (0.3%) & peptides (1%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ANTI-ACNE SERUM
Salicylic acid (0.5%) & Copper Tripeptide-1 (1%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ANTI-AGING GEL
Niacinamide & Argireline peptide (2%) |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ANTI-AGING TONER
Argireline Peptide (1%) & Niacinamide (2%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ANTI-PIGMENTATION SERUM
Tranexamic Acid (3%) & Niacinamide (3%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ANTI-WRINKLE GEL
Argireline peptide (2%) |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
BRIGHTENING CREAM
Niacinamide (2%) & Nonapeptide-1 (0.004%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
CLEAR GLOW TONER
Niacinamide (1%) & Alpha arbutin (1%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
DEEP HYDRATION GEL
Hyaluronic Acid (1%) |
DDose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At 24 hours post-application,
patches will be removed and skin will be evaluated for
irritation reactions at 30 mins,24 hours (Day 1) post
patch removal and 168 hours (Day 7) post-patch removal
(if needed). Frequency: single application Duration: 09 days. |
| Intervention |
EVER GLOW FACE WASH
Niacinamide (1%) & Saffron extract (1%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
FACE TONER Sodium hyaluronate (1%) & Ceramide complex (0.5%) |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
MOISTURIZING CREAM
Copper Tripeptide-1 (1%) & Ceramide complex (0.5%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Comparator Agent |
Positive Control- 1% and 3%
w/v Sodium Lauryl Sulphate (SLS) analytical grade |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion or semi occlusion application for 24 hours. At
24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single
application Duration: 09 Days |
| Intervention |
ROOT NOURISHMENT HAIR OIL
Multi-oil complex & Vitamin E |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
ROOT REVIVE HAIR SERUM
Copper Tripeptide-1 (1%) & Sodium Hyaluronate (0.2%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Comparator Agent |
sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At
24hours post-application, patches will be removed and
skin will be evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single
application Duration: 09 Days |
| Intervention |
SUN SCREEN SPF50 |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
SUPER ANTI-AGING SERUM
Argireline peptide (1%) & Sodium Hyaluronate (2%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
SUPER CLEANSING CREAM
Vitamin C (1%) & Copper Tripeptide-1 (0.5%) |
Dose: 0.04mL Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
| Intervention |
UNDER EYE CREAM
Matrixyl 3000 (2%) & Eyeliss (0.5%) |
Dose: 0.04mL Route of administration: Topical mode of usage: Products will be evaluated through the complete
occlusion and applied for 24 hours. At 24 hours post-application. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application Duration: 09 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18-65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
4) Females of childbearing potential must have a self-reported negative pregnancy test.
5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
6) Subject is in good general health as determined by the Investigator on the basis of medical history.
7) Subjects is willing to maintain the test patches in designated positions for 24 Hours.
8) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
9) Subject must be able to understand and provide written informed consent to participate in the study.
10) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
11) For Sensitive Specific Skin Study Only:
• Subject scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin
in modified Dr Baumann’s skin type questionnaire.
• Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.
|
|
| ExclusionCriteria |
| Details |
1) Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
2) Medication which may affect skin response and/or past medical history.
3) Subject having history of diabetes
4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
5) Subject suffering from any active clinically significant skin diseases which may contraindicate.
6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
7) Participation in any patch test for irritation or sensitization within the last four weeks.
8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
9) Use of any:
i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
10) Topical drugs used at application site.
11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
12) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
13) Subject with known allergy or sensitization to medical adhesives, bandages.
14) Participation in other patch study simultaneously.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the test products by 24 Hours Patch Test |
Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours
post-patch removal if needed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Safety of the skin by visual dermatological assessment |
At T30 minutes & 24 hours post patch removal. Scoring can be done at T168 hours post-patch
removal if required] |
|
|
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)
|
15/08/2025 |
| 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="0"
Days="9" |
|
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
|
This is single-centre, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 24 hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total three visits in this study and one are optional visit. Visit 01 (Day01):Screening, Lactic Acid Stinging Test & Modified Dr Baumann’s skin type questionnaire, Enrollment and Patch Application, Visit 02 (Day 02): Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03 (Day 03): 24 (± 2 hour) irritation scoring (Day 03)Visit04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery(optional deemed necessary)Irritation scoring at 168 ± 2 hours post-patch removal(Day 09). |