CTRI/2021/07/034826 [Registered on: 14/07/2021] Trial Registered Prospectively
Last Modified On:
26/07/2023
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
To Assess the skin irritation potential of face wash, Sunscreen and night cream, by repeated application of patches on human skin.
Scientific Title of Study
To assess the skin irritation and sensitization potential of the 3 Investigational products by repeated application of occlusive patches.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vrushali Nikam
Designation
Consultant Dermatologist- Skinovate Laser and Cosmetic Surgery center
Affiliation
Skinovate Laser and Cosmetic Surgery center
Address
Office no. 303, Third floor, ‘Royal avenue’, Survey no. 18, Hissa no. 11/6
Next to Hotel Shivar garden, Pimple Saudagar, Rahatani, Taluka- Haveli, Pune- 411017
Pune MAHARASHTRA 411017 India
Phone
9665041290
Fax
-
Email
drvrushali.research@gmail.com
Details of Contact Person Scientific Query
Name
Dr Vrushali Nikam
Designation
Consultant Dermatologist- Skinovate Laser and Cosmetic Surgery center
Affiliation
Skinovate Laser and Cosmetic Surgery center
Address
Office no. 303, Third floor, ‘Royal avenue’, Survey no. 18, Hissa no. 11/6
Next to Hotel Shivar garden, Pimple Saudagar, Rahatani, Taluka- Haveli, Pune- 411017
Pune MAHARASHTRA 411017 India
Phone
9665041290
Fax
-
Email
drvrushali.research@gmail.com
Details of Contact Person Public Query
Name
Dr Vrushali Nikam
Designation
Consultant Dermatologist- Skinovate Laser and Cosmetic Surgery center
Affiliation
Skinovate Laser and Cosmetic Surgery center
Address
Office no. 303, Third floor, ‘Royal avenue’, Survey no. 18, Hissa no. 11/6
Next to Hotel Shivar garden, Pimple Saudagar, Rahatani, Taluka- Haveli, Pune- 411017
Pune MAHARASHTRA 411017 India
Phone
9665041290
Fax
-
Email
drvrushali.research@gmail.com
Source of Monetary or Material Support
COSMETICA
Primary Sponsor
Name
Mr Amol Khedkar
Address
COSMETICA
D/2, Prakash Society, Near Kalewadi Fata, Thergaon, Pune-411033, Maharashtra, INDIA.
Type of Sponsor
Other [SELF]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sushil Chaudhary
Skinovate Laser and Cosmetic Surgery center
Office no. 303, Third floor, ‘Royal avenue’, Survey no. 18, Hissa no. 11/6, Next to Hotel Shivar garden, Pimple Saudagar, Rahatani, Taluka- Haveli, Pune- 411017. Pune MAHARASHTRA
9665041290 - sushilrc.chaudhary@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
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
1.To ascertain the irritation potential of 3 investigational products after removal of occlusive patch after every 24 (±2)
2.To evaluate the general safety of 3 investigational products.
Intervention / Comparator Agent
Type
Name
Details
Intervention
Face wash
Subjects will be exposed to a 24 ±2 hour dermal application of the experimental investigational product repeatedly during induction phase & Challenge phase.
Intervention
Night Cream
Subjects will be exposed to a 24 ±2 hour dermal application of the experimental investigational product repeatedly during induction phase & Challenge phase.
Comparator Agent
Normal saline (0.9% aqueous solution of Sodium Chloride)
Subjects will be exposed to a 24 ±2 hour dermal application of the control repeatedly during induction phase & Challenge phase.
Intervention
Sunscreen
Subjects will be exposed to a 24 ±2 hour dermal application of the experimental investigational product repeatedly during induction phase & Challenge phase.
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
Exclusion Criteria:
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
Trained evaluator assessment of product tolerability through Draize scale (Dermal response) on D2, D4, D6, D8, D10, D12, D14, D16, D18 and D35, D36, D37
Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18 and Day 35, Day 36, Day 37
Secondary Outcome
Outcome
TimePoints
Frequency and severity of Adverse Events
Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18 and Day 35, Day 36, Day 37
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An
evaluator (single) blind, test site 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.