| CTRI Number |
CTRI/2025/06/088409 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Test on Adult Healthy Human Subjects with Sensitive Skin. (Single Application 24 hours Complete Occlusion) |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Sensitive Skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04978-DAB-F, Version: 01, Dated 20 May 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Y Srinivasa Reddy |
| Designation |
Assistant Manager – Medical Affairs & Clinical Research |
| Affiliation |
Dabur Research and Development Centre |
| Address |
Dabur India Limited,
Dabur Research and Development Centre, Dabur India Limited, Plot
no 22, Site 4, Sahibabad , Ghaziabad 201010-India
Phone: (0120) 3378638
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
3378638 |
| Fax |
|
| Email |
Srinivasa.Yathapu@dabur.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research,
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
|
| Dabur India Limited
Dabur Research & Development Centre
Plot No.22, Site IV, Sahibabad-201010,
Ghaziabad (U.P.), India.
Tel: (0120) 3378638
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research & Development Centre
Plot No.22, Site IV, Sahibabad-201010,
Ghaziabad (U.P.), India.
Tel: (0120) 3378638
|
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad, Gujarat.-380054.
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 65 years healthy adult male & female with sensitive skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gel (DRDC/2024/018) |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Comparator Agent |
Negative Control |
Neat, 0.9gm of Sodium Chloride in 100ml of distilled water (0.9% w/v) , 0.04 ml, single dose, topical application, 24 hr |
| Comparator Agent |
Positive Control |
1 gm of SLS in 100 mL of distilled water (1 % w/v) , 0.04 ml, single dose, topical application, 24 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
2. Subjects with normal Fitzpatrick skin type III to V. (Human skin colour determination scale).
3. Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4. Subjects scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire.
5. Subjects who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
6. Subjects are in good general health as determined by the Investigator on the basis of medical history.
7. Subjects willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
8. Subjects willing and able to follow the study directions to participate in the study, return for all specified visits.
9. Subjects must be able to understand and provide written informed consent to participate in the study.
10. Subjects having valid proof of identity and age.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and 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. Subject with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
3. Subject suffering from any active clinically significant skin diseases which may affect the study results.
4. Subject having history of any skin diseases including eczema, atopic dermatitis.
5. Participation in any patch test for irritation or sensitization within the last four weeks. Participation in other patch study simultaneously.
6. Subjects with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
7. Subjects with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
8. Subject with known allergy or sensitization to medical adhesives, bandages.
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 (steroids nose drops and/or eye drops are permitted).
iv. Topical drugs used at application site.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety assessment of products |
30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
25/06/2025 |
| Date of Study Completion (India) |
18/06/2025 |
| 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
|
Cosmetics products commonly referred to
as personal care products are used by most people on a day to day basis. These
products and materials can be potential sources of cutaneous irritation which
makes it a necessity to ensure their safety for usage.
Several types of test methods are used
widely for the evaluation of safety of cosmetics in human, which include single
patch test, in-use test, 7/14/24 Days cumulative irritation patch testing,
human repeated insult patch test (HRIPT) for irritation and sensitization
potential. Primary Irritation Patch Test is
performed to evaluate the primary skin irritation that can range from none,
mild, moderate to severe irritation. This results from reversible inflammatory
changes in the skin following the application of a test substance depending on
the irritation potential of the product. Based on the severity of irritation
caused due to the interaction of ingredients or composition of the test
substance with the skin can cause perceivable sensations or symptoms. On the
basis of this, the possible hazards likely to arise from exposure of the skin
to the test substance can be assessed. To know the safety or possible irritant
potential of these products, it should be tested in small group of humans
before release of the product in market. This allows to measure and evaluate
the probable inflammatory response to an irritant which occurs only at the site
of exposure. The response tends to be universal (produces a reaction in most
individuals) and depends on the strength and duration of exposure.
|