| CTRI Number |
CTRI/2021/07/034854 [Registered on: 14/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic claim study ] |
| Study Design |
Other |
|
Public Title of Study
|
To Assess the irritation potential of face wash, Sunscreen and night cream, by repeat application of patches on human skin. |
|
Scientific Title of Study
|
To evaluate the skin irritation and sensitisation potential of the 3 Investigational products by repeated application of occlusive patches. |
| Trial Acronym |
LPR/SKI-002 |
|
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 |
Lifepoint Multispecialty Hospital |
| Address |
3rd floor, Research Department, Lifepoint Multispecialty Hospital, Mumbai Bangalore Highway, Near Sayaji Hotel, Wakad, Pune-411057, Maharashtra, INDIA.
Pune
MAHARASHTRA
411057
India |
| Phone |
9665041290 |
| Fax |
|
| Email |
shendkar.sonal82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Lifepoint Multispecialty Hospital |
| Address |
3rd floor, Research Department, Lifepoint Multispecialty Hospital, Mumbai Bangalore Highway, Near Sayaji Hotel, Wakad, Pune-411057, Maharashtra, INDIA.
Pune
MAHARASHTRA
411057
India |
| Phone |
9665041290 |
| Fax |
|
| Email |
shendkar.sonal82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Chaudhary |
| Designation |
Project Head |
| Affiliation |
Lifepoint Multispecialty Hospital |
| Address |
3rd floor, Research Department, Lifepoint Multispecialty Hospital, Mumbai Bangalore Highway, Near Sayaji Hotel, Wakad, Pune-411057, Maharashtra, INDIA.
Pune
MAHARASHTRA
411057
India |
| Phone |
9890840086 |
| Fax |
|
| Email |
drsunilchaudhary07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SKINOVATE LASER & COSMETIC SURGERY CENTRE |
|
|
Primary Sponsor
|
| Name |
SKINOVATE LASER COSMETIC SURGERY CENTRE |
| Address |
SKINOVATE LASER & COSMETIC SURGERY CENTRE, Royal Avenue, office no. 303, near Shivar garden restaurant, Pimple Saudagar, Rahatani, Pune- 411017. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sunil Chaudhary |
Lifepoint Multispecialty Hospital |
3rd floor, Research Department, Lifepoint Multispecialty Hospital, Mumbai Bangalore Highway, Near Sayaji Hotel, Wakad, Pune-411057, Maharashtra, INDIA.
Pune
MAHARASHTRA |
9890840086
drsunilchaudhary07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LPR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult Healthy Volunteers between age 18 to 65 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control |
Normal saline (0.9% aqueous solution of Sodium Chloride)- repeated occlusive Patches to be applied on back of subject skin during induction phase & challenge phase. |
| Intervention |
Positive Control |
1. SKINOVATE Face wash- repeated occlusive Patches to be applied on back of subject skin during induction phase & challenge phase.
2. SKINOVATE Sunscreen- repeated occlusive Patches to be applied on back of subject skin during induction phase & challenge phase.
3. SKINOVATE Night cream- repeated occlusive Patches to be applied on back of subject skin during induction phase & challenge phase.
Positive Control – Sodium Lauryl Sulfate (1% w/w in distilled water)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
3. Subjects who have intact skin on the proposed application site; dorsum (scapular region)
4. Fitzpatrick photo type I to IV skin type
5. Willingness to participate as evidenced by voluntary written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast-feeding
3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) 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 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.
7. History of diseases aggravated or triggered by 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 vitamin A 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 allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
14. Previous history of atop, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication
15. Known or suspected intolerance or hypersensitivity to any of the study
materials (or closely related compounds) or any of their stated ingredient including any component of the patches
16. History of sensitization in a previous patch study
17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
18. Recent history (within the last years) of alcohol or other substance abuse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the irritation potential of 3 investigational products after removal of occlusive patch after every 24 (±2) hours in sequential manner for 37 days which includes 18 days of Induction phase, 14 days Resting phase & 5 days of Challenge phase to the skin of healthy volunteers. |
D1 to D18, 18 days of Induction phase
D19 to D32, 14 days of resting phase
D33 to D36, 5 days of Challenge Phase
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the general safety of 3 investigational products. |
assessed during, D1 to D18, 18 days of Induction phase
D19 to D32, 14 days of resting phase
D33 to D36, 5 days of Challenge Phase |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/07/2021 |
| 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="1"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open label, Non-randomized and intra-subject comparison of repeated insult patch test study to evaluate the cutaneous irritation potential of three experimental investigational products, including a control. Following provision of informed consent and completion of all screening assessments, eligible subjects will be enrolled in the study. Study is conducted over a period of 37 days for each subject. Products will be evaluated through repeated application via occlusive patches onto the dorsum scapular region skin of healthy males & behind upper left arm for healthy females for a 24-hour period on D1, D3, D5, D7, D9, D11, D13, D15, D17& post patch removal evaluation shall be done by Principal investigator for grading. Patches will be removed after 24 hours and the skin will be assessed for any signs of irritation on D2, D4, D6, D8, D10, D12, D14, D16, D18, this phase of the study is called as Induction Phase. From D19 till D32- resting Phase will be there where in no study activities shall be performed, this will be wash out period. From D33 till D36 Challenge phase will be there, where in subjects will be applied Patch on D33, removal shall be done after 24 hours, Dermatologic evaluation will be done 24 hours post patch removal, then post 48 hours, & lastly post 72 hours. Assessments Subjects will undergo visual evaluations of dermal irritancy performed by a trained assessor on D2, D4, D6, D8, D10, D12, D14, D16, D18 in induction phase. Once again visual evaluations of dermal irritancy performed by a trained assessor on D35, D36, D37 in Challenge phase. The Draize scores will be analyzed to establish the irritation potential of each test product in Induction phase. While in Challenge phase ICDRG scale will be used to see the irritation potential of each test product. Subjects will be assessed for frequency and severity of adverse events. |
|