| CTRI Number |
CTRI/2024/12/077841 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cosmetic Clinical Study |
| Study Design |
Other |
|
Public Title of Study
|
We want to test how the investigational product (IP) might affect the skin and check if its safe to use by applying it on the skin of 24 healthy volunteers for 24 hours. This will help us understand if it causes any irritation or discomfort. |
|
Scientific Title of Study
|
To assess the irritational potential and safety of the given investigation product (IP) by a 24-hour patch test in 24 healthy human volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser & Cosmetic Surgery Centre |
| Address |
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Pune
MAHARASHTRA
411017
India |
| Phone |
9960178611 |
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser & Cosmetic Surgery Centre |
| Address |
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Pune
MAHARASHTRA
411017
India |
| Phone |
9960178611 |
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Chaudhary |
| Designation |
Director |
| Affiliation |
Skinovate Laser & Cosmetic Surgery Centre |
| Address |
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Skinovate Laser & Cosmetic Surgery Centre Office No 303 Third Floor Royal Avenue Next to Hotel Shivar Garden Pimple Saudagar Rahatani Maharashtra 411017
Pune
MAHARASHTRA
411017
India |
| Phone |
9665041290 |
| Fax |
|
| Email |
info@skinovate.in |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Limited.19/1, 19/2, I Main, II Phase
Peenya Industrial Area
Bangalore – 560058
|
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Limited |
| Address |
19/1, 19/2, I Main, II Phase
Peenya Industrial Area
Bangalore – 560058
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonal Shendkar |
Skinovate Laser and cosmetic center |
Skinovate laser and cosmetic center Office No. 302 and 303, Third Floor, ‘Royal Avenue’, Survey No.18 Hissa No.11/6, Next to Hotel ‘Shivar Garden Pimple Saudagar, Rahatani, Maharashtra 411017
Pune
MAHARASHTRA |
07385126865
drsonal.skinovate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skinovate Independent Thics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Must provide a voluntarily signed written informed consent form and must be willing to follow the guidelines as mentioned in the protocol.
2. Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
3. Subjects should be in good general and mental health condition as per the assessment and opinion of the investigator or a medically qualified designee with no clinically significant abnormalities in medical history or upon physical examination
4. Subjects must have an intact skin on the proposed application site; (dorsum scapular region and the upper forearm region)
5. Skin type that belongs to Fitzpatrick photo type I to VI.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Women who are known to be pregnant or who intend to become pregnant during the study period.
2. Women who are breast-feeding
3. Any history of significant dermatological diseases or medical conditions known to alter skin appearance which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
4. Presence of any open sores, pimples, or cysts at the application site.
5. Active dermatosis (local or disseminated) that might interfere with the results of the study.
6. Considered immune compromised by the PI.
7. Medical history of any allergies or reactions triggered by exposure to sunlight or ultraviolet radiation.
8. Participants with dermatographism.
9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
11. Oral or topical treatment with retinoic acid and/or its derivatives up to 1 month before the screening visit
12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
13. Currently receiving injections or medications to treat allergies.
14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings on usage of topical products, cosmetics, or medications.
15. Known or suspected intolerance or hypersensitivity to any of the ingredients present in the investigational product.
16. History of sensitization in any of the patch tests conducted earlier.
17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational product within 30days of the screening visit
18. Recent history (within the last 6 months) of alcohol or other substance abuse
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary analysis for skin irritation will be based on the Draize scale score assigned by the primary investigator/dermatologist/designee.
|
Day 2 & Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety and tolerability will be evaluated based on the incidence, frequency & the casual relationship between the AE/SAE and the investigational product.
The AE/SAE data will be summarized by presenting the number and percentage of subjects having any AE/SAE.
|
Day 2 & Day 3 |
|
|
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)
|
30/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to evaluate the skin irritation and safety of an investigational product (IP) through a patch test on healthy volunteers. The primary objective is to assess skin irritation potential after applying the product with an occlusive patch for 24 hours. The secondary objective is to evaluate general safety using the Draize scale score. Key details: Study Duration: 3 days per subject Test Area: Dorsum scapular region (males) or left upper arm (females) Inclusion Criteria: Healthy adults aged 18-65, no dermatological conditions, intact skin at the test site, and Fitzpatrick skin types I to VI. Exclusion Criteria: Pregnant/breastfeeding women, active skin conditions, certain medications (e.g., immunosuppressants, antihistamines), history of allergies or reactions to skin products, and participation in other clinical studies within 30 days. The product will be applied on the test site, covered for 24 hours, and evaluated for skin irritation (redness, dryness, etc.) on Day 2 and Day 3. Safety will be monitored based on adverse events during the study. The irritation potential will be assessed by a trained dermatologist using the Draize scale. Primary Variables:
The primary analysis of skin irritation will be conducted using the Draize scale score, which will be assigned by the primary investigator, dermatologist, or designee. Safety Variables:
The safety and tolerability of the investigational product will be evaluated based on: The incidence and frequency of Adverse Events (AE) and Serious Adverse Events (SAE). The causal relationship between the AE/SAE and the investigational product will be assessed. The AE/SAE data will be summarized by showing the number and percentage of subjects who experience any AE or SAE |