To assess the safety of test products on skin

Completed

Conditions: healthy

Registration Number: CTRI/2022/03/040983

Lead Sponsor: ITC LSTC

Brief Summary: **Objective: To evaluate thedermatological safety of investigational product.**

**Duration of study: 10 days study**

**Kinetics:T0 (**Evaluation of test sites by Dermat and Subject,

Plaster application),**T2 (48 hrs) (**Plasterremoval, Evaluation of test sites by Dermat and Subject post 30 minutes ofplaster removal**), T3(**Evaluationof test sitesbyDermat and Subject post 24 hrs of plaster removal**), T9** **(**Evaluation of test sitesbyDermat and Subject post 1 week of plaster removal and tracking the positivecases**)**

**Population 24 healthy subjects(12males + 12 females) The subjects are selected on the**

**basis of skin types:**

3 males + 3 females for dry skin

3 males + 3 females for oily skin

3 males + 3 females for combinationskin

3 males + 3 females for normal skin

**Products:** Plaster1[9740892], Plaster 2 [W547]

**The test area is checked forerythema and oedema caused due to the products.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

Healthy & Clear Skin on back on the studied anatomic unit (free of psoriasis, eczema, , lichen plan, vitiligo, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies â€¦.) Male and female volunteers in the age group of 18 to 50 years in generally good health Volunteer willing to participate in the study and provide signed informed consent for the same Subjects representing varied skin types (ideally equal representation of all 4 skin types â€“ Oily, Normal, Dry and combination).

Exclusion Criteria

Volunteers hesitant to sign on Informed consent forms Volunteers with known sensitivity to bandage or adhesive tape Volunteer who has participated in a similar clinical investigation in the last four weeks of study initiation Volunteer who is considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk Volunteers with sunburns, uneven skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality on their back that would render the site non-conducive for visual assessment.
Volunteers identified with clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations Volunteers on medication such as Antihistamines, Antifungals, Corticosteroids, Topical Steroids, etc.
that might influence the study results Female volunteers who are Pregnant or lactating.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of	screening T0 T1day T2days T8days
investigational products by Single Application Closed patch test on healthy human volunteers of varied	screening T0 T1day T2days T8days
skin types.	screening T0 T1day T2days T8days

Secondary Outcome Measures

Name	Time	Method
not applicable	not applicable

Trial Locations

Locations (1): MASCOT-SPINCONTROL India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
MASCOT-SPINCONTROL India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Siddheshwar Mathpati
Principal investigator
022-43349191
siddheshwar@mascotspincontrol.in