Primary Irritation patch Testing on Adult Healthy Human Subjects with Sensitive Skin.

Completed

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

• Registration Number: CTRI/2022/12/048242
• Lead Sponsor: Honasa Consumer Pvt. Ltd.

Brief Summary

Cosmetics and AyurvedicMedicines commonly referred to as personal care products are used by mostpeople on a day to day basis. These products and materials can be potentialsources of cutaneous irritation which makes it a necessity to ensure theirsafety for usage.

Several types of testmethods are used widely for the evaluation of safety of cosmetics in human,which include single patch test, in-use test, 7/14/24 days cumulativeirritation patch testing (CIPT), human repeated insult patch test (HRIPT) forirritation and sensitization potential.

Primary Irritation Patch Test (PIPT)is used to determine the potential of the test articles to cause cutaneousirritation in adult human subjects after single 24-hour occluded patchapplication.

Primary Irritation PatchTest (PIPT) is performed to evaluate the primary skin irritation that can rangefrom none, mild, moderate to severe irritation. This results from reversibleinflammatory changes in the skin following the application of a test substancedepending on the irritation potential of the product. Based on the severity ofirritation caused due to the interaction of ingredients or composition of thetest substance with the skin can cause perceivable sensations or symptoms. Onthe basis of this, the possible hazards likely to arise from exposure of theskin to the test substance can be assessed. To know the safety or possibleirritant potential of these products, it should be tested in small group ofhumans before release of the product in market. This allows to measure andevaluate the probable inflammatory response to an irritant which occurs only atthe site of exposure. The response tends to be universal (produces a reactionin most individuals) and depends on the strength and duration of exposure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Study Completion: 2022-12-27
• Last Update Posted: 2023-04-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 1)Age: 18-65 years (both inclusive) at the time of consent.
• 2)Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• 3)Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
• 4)Females of childbearing potential must have a negative urine pregnancy test performed on Day 00 prior to patch application.
• 5)Subjects scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire.
• 6)Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• 7)Subject is in good general health as determined by the Investigator on the basis of medical history.
• 8)Subjects willing to maintain the test patches in designated positions for 24 Hours.
• 9)Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• 10)Subject must be able to understand and provide written informed consent to participate in the study.
• 11)Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.

Exclusion Criteria

• 1)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.
• 2)Medication which may affect skin response and/or past medical history.
• 3)Subject having history of diabetes 4)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.
• 5)Subject suffering from any active clinically significant skin diseases which may contraindicate.
• 7)Participation in any patch test for irritation or sensitization within the last four weeks.
• 8)Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
• 9)Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
• 10)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.
• 11)Subject with known allergy or sensitization to medical adhesives, bandages.
• 12)Participation in other patch study simultaneously.
• 13)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) 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

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Parth Joshi

Principal investigator

8000085049

pjoshi@cliantha.com