Primary Irritation Patch Test (PIPT) Study Conducted at NovoBliss Research for Shared Panel

Summary

This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events.

The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.

Conditions

• Healthy

Interventions

OTHER

Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide

Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.

OTHER

Peptide complexed HA Age Defying Gel with Natural Extracts

Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.

OTHER

Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts

Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.

OTHER

1% w/v Sodium Lauryl Sulphate (SLS) solution

1g of Sodium Lauryl Sulphate will be dissolved in distilled water and made up to 100 mL solution using distilled water. A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.

OTHER

Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v

A 0.04 mL of 0.9% w/v solution of Isotonic Saline Solution will be dispensed on the center of an appropriately sized filter paper, which will be further placed in the designated IQ/Finn chambers prefixed to a micropore tape.

Sponsors & Collaborators

• Nanobrid Innovations Private Limited

  collaborator INDUSTRY

• NovoBliss Research Pvt Ltd

  lead OTHER

Principal Investigators

• Dr Nayan K Patel, MBBS · Medical Director

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-05

Primary Completion

2022-12-13

Completion

2022-12-20