Primary Irritation Patch Test (PIPT) for Normal Skin (Single Application 24 hour Occlusion)

Not yet recruiting

• Conditions: 18 to 65 years healthy adult male & female with normal skin of varied Skin types (Oily, Dry, Normal and Combination).

• Registration Number: CTRI/2025/06/088274
• Lead Sponsor: Dabur India Limited

Brief Summary

Cosmetics commonly referred to aspersonal care products are used by most people on a day to day basis. Theseproducts and materials can be potential sources of cutaneous irritation whichmakes it a necessity to ensure their safety for usage.

Several types of test methods are usedwidely for the evaluation of safety of cosmetics in human, which include singlepatch test, in-use test, 7/14/24 Days cumulative irritation patch testing,human repeated insult patch test (HRIPT) for irritation and sensitizationpotential.

Primary Irritation Patch Test isperformed to evaluate the primary skin irritation that can range from none,mild, moderate to severe irritation. This results from reversible inflammatorychanges in the skin following the application of a test substance depending onthe irritation potential of the product. Based on the severity of irritation causeddue to the interaction of ingredients or composition of the test substance withthe skin can cause perceivable sensations or symptoms. On the basis of this,the possible hazards likely to arise from exposure of the skin to the testsubstance can be assessed. To know the safety or possible irritant potential ofthese products, it should be tested in small group of humans before release ofthe product in market. This allows to measure and evaluate the probableinflammatory response to an irritant which occurs only at the site of exposure.The response tends to be universal (produces a reaction in most individuals)and depends on the strength and duration of exposure.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

• 1)Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and 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.
• 2)Subject with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
• 3)Subject suffering from any active clinically significant skin diseases which may affect the study results.
• 4)Subject having history of any skin diseases including eczema, atopic dermatitis.
• 5)Participation in any patch test for irritation or sensitization within the last four weeks.
• 6)Subjects taking part in another study liable to interfere with the results of this study.
• 7)Subjects with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
• 8)Subjects with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
• 9)Subject with known allergy or sensitization to medical adhesives, bandages.
• 10)Use of any: I.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
• III.Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroids nose drops and/or eye drops are permitted).
• IV.Topical drugs used at application site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Assessment of Products	30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Bhagirath Patel

Principal investigator

9825618138

bpatel3@cliantha.com