Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types

Completed

Conditions: Subjects having dandruff

Registration Number: CTRI/2018/03/012314

Lead Sponsor: ITC LIMITED ITC Life Sciences and Technology Centre

Brief Summary: Single Application, occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.

**Objective: To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.**

**Duration of study: 8 days study**

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

Patch application)**,****T+30mins** post patch application, **T1(**Patch removal, Evaluation of test sites by Dermat and Subject post 30 minutes of patch removal**), T2(**Evaluation of test sitesby Dermat and Subject post 24 hrs of patch removal**), T8 (**Evaluation of test sitesby Dermat and Subject post 1 week of patch removal and tracking the positive cases**)**

**Population 24 healthy subjects(12 males + 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 combination skin

3 males + 3 females for normal skin

**Products:**Soap (TSP 108-165), Soap (TSP 118-01B), Soap (TSP 118-02B), Soap (TSP 118-03B), Soap (TSP 118-04B), Soap (TSP 118-05B), Soap (TSP 118-06B), Soap (TSP 118-07B), Soap (TSP 115-170A), Soap (TSP 115-170B).

**Positive control: 3% SLS**

**The test area is checked for erythema and oedema caused due to the products and**

**compared with positive control**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ€¦.) Subjects representing varied skin types (ideally equal representation of all 4 skin types â€“ Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period.

Exclusion Criteria

For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patch test on healthy human volunteers of varied	T0 \| T30 minutes post patch application \| T1 \| T2 \| T8
To evaluate the dermatological safety of	T0 \| T30 minutes post patch application \| T1 \| T2 \| T8
investigational products by primary irritation	T0 \| T30 minutes post patch application \| T1 \| T2 \| T8
skin types	T0 \| T30 minutes post patch application \| T1 \| T2 \| T8

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