| CTRI Number |
CTRI/2025/09/095110 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Dermatological Safety and Skin Compatibility Evaluation of Test Products |
|
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 |
| NB250039-OL, Version 1.0, 12Jun25 |
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
|
| OneSto Labs Private Ltd. Plot no. 309, Sector 6, IMT Manesar, Gurugram, Haryana 122052 |
|
|
Primary Sponsor
|
| Name |
OneSto Labs Private Ltd. |
| Address |
Plot no. 309, Sector 6, IMT Manesar, Gurugram, Haryana 122052 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
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 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 |
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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bare anatomy expert advanced hair density serum |
Dose: 0.1 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
| Intervention |
Bare Anatomy Expert Ultra Hair Growth Hair Serum |
Dose: 0.1 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
| Intervention |
Bare anatomy expert Ultra- Smoothing Hair Mask |
Dose: 0.1 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
| Intervention |
Bare Anatomy Expert Ultra- Smoothing Shampoo |
Dose: 0.1 ml of 8% w/v sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
| Comparator Agent |
Positive Control- 1% w/v Sodium Lauryl Sulphate (SLS) analytical grade |
Dose: 0.1 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
| Comparator Agent |
sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v |
Dose: 0.1 ml Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. At 48 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 +5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04), 48±2 hours of patch removal (Day 05) |
|
|
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 product by 48 Hours Patch Test Under
Complete Occlusion. |
30+5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04) and 48±2 hours of patch removal (Day 05) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Change in Transepidermal Water Loss (TEWL) by TEWAMeter TM Hex at the application site |
at baseline, 30 mins and 24 hours post patch removal |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
11/10/2025 |
| 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
|
This is single-centre, evaluator blinded study in healthy human subjects. single 48-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 48hours (± 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 four visits in this study. Visit 01 (Day01):Screening, Enrollment and Patch Application, Visit 02 (Day 03): Patch Removal & 30 ± 5 min irritation scoring upon patch removal. Visit 03 (Day 04): 24 (± 2 hour) irritation scoring (Day 04)Visit 05: At 48±2 hours Irritation Scoring |