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

NCT05642702 | Unknown

• 2 other identifiers: NBSP22-PIPTNBSP22-PIPT-0030-NI
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from Irritation Potential of the test product from Baseline to Post application

  To evaluate the dermatological irritation potential of the test products by applying Patch Test Under Complete Occlusion for continuous 24 Hours exposure on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination)

  Irritation Scoring at 30 minutes, and 24 hours, 168 hours post patch removal.

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  At 30 minutes (on Day2) and 24 hours (on Day 3) post patch removal and up to 9 days from the Day 1.

Study Arms (5)

Test Product Code A

EXPERIMENTAL

Peptide complexed HA Age Defying Gel with Vitamin C \& Niacinamide -

Other: Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide

Test Product Code B

EXPERIMENTAL

Peptide complexed HA Age Defying Gel with Natural Extracts

Other: Peptide complexed HA Age Defying Gel with Natural Extracts

Test Product Code C

EXPERIMENTAL

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

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

Positive Control

ACTIVE COMPARATOR

Sodium Lauryl Sulphate (SLS) analytical grade 1 % w/v

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

Negative Control

ACTIVE COMPARATOR

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

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

Interventions

Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide OTHER

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.

Also known as: Skin Care product

Test Product Code A

Peptide complexed HA Age Defying Gel with Natural Extracts OTHER

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.

Also known as: Skin Care product

Test Product Code B

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

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.

Also known as: Skin Care product

Test Product Code C

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

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.

Also known as: Positive Control

Positive Control

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

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.

Also known as: Negative Control

Negative Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years (both inclusive) at the time of consent.
• Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
• Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
• Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• Subject is in good general health as determined by the Investigator on the basis of medical history.
• Subjects is willing to maintain the test patches in designated positions for 24 Hours.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• Subject must be able to understand and provide written informed consent to participate in the study.
• Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.

You may not qualify if:

• Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
• Medication which may affect skin response and/or past medical history.
• Subject having history of diabetes
• Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
• Subject suffering from any active clinically significant skin diseases which may contraindicate.
• Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
• Participation in any patch test for irritation or sensitization within the last four weeks.
• Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
• Use of any:
• i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
• ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
• iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
• Topical drugs used at application site.
• Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
• Individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Nanobrid Innovations Private Limited: collaborator

MeSH Terms

Interventions

Ascorbic Acid; Niacinamide; long-chain-aldehyde dehydrogenase; Solutions; Sodium Chloride

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dr Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel, M.Pharma

CONTACT

91-9909013236; maheshvari@novobliss.in

Sheetal Khandwala, B.Com

CONTACT

91-9909013286; dr.nayan@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator Blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 8, 2022
• Study Start: December 5, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 20, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share