To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects

Completed

• Conditions: Adequate representation of varied skin types

• Registration Number: CTRI/2023/06/053595
• Lead Sponsor: DPKA Universal Consumer Venture Private Limited |82°E

Brief Summary

This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion | semi occlusion | open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event.

A sufficient number 26 subject will be enrolled to get 24 completed the study.



There are total three visits in this study and are optional visit



Pre-screening visit : Lactic Acid Stinging test& Modified Dr baumenn’s skin type questionnaire.

Visit 01: Screening, Enrollment, and Patch Application (Day 01).



Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal.



Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site.



Follow-up visit for reactions if any to confirm recovery (optional deemed necessary).



Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Study Completion: 2023-06-20
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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.
• The subject is in good general health as determined by the Investigator on the basis of medical history.
• Subjects are 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 is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given.

Exclusion Criteria

• 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 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.
• Subject suffering from any active clinically significant skin diseases which may contraindicate.
• 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.
• Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
• Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10.
• 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.
• Subject with known allergy or sensitization to medical adhesives, bandages.
• Participation in other patch study simultaneously.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the test	30 mins, 24 Hour & 168 hour (if needed).
products by 24 Hours Patch Test Under	30 mins, 24 Hour & 168 hour (if needed).
Complete Occlusion on healthy adult human	30 mins, 24 Hour & 168 hour (if needed).
subjects & adequate representation of varied	30 mins, 24 Hour & 168 hour (if needed).
skin types (Oily, Dry, Normal & Combination).	30 mins, 24 Hour & 168 hour (if needed).

Secondary Outcome Measures

Name	Time	Method
Safety of the skin	At 30 mins & 24 hours post patch removal.

Trial Locations

Locations (1)

NovoBliss Research Pvt. Limited; 🇮🇳 Gandhinagar, GUJARAT, India

NovoBliss Research Pvt. Limited

🇮🇳Gandhinagar, GUJARAT, India

Dr Nayan Patel

Principal investigator

9909013286

dr.nayan@novobliss.in