To check Dermatological Safety of Test Product by 24 Hours Patch Test

Not yet recruiting

• Conditions: Adequate representation of varied skin types

• Registration Number: CTRI/2025/06/089210
• Lead Sponsor: Sun Chem India

Brief Summary

This is single-centre, evaluator blinded study in healthy human subjects. single 24-hourapplication of sponsors provided test product along with positive and negative control willbe kept in contact with the skin if subject under inclusion | semi occlusion | open patch forat least 24 hours (± 2hours).safety will be assessed through the study by monitoring ofadverse event. A sufficient number 26 subject will be enrolled to get 24 to complete thestudy. 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 24hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08for any signs of irritation at patch application site. Follow-up visit for reactions if any toconfirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-17
• Study Start: 2027-07-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• 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 self-reported negative pregnancy test 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• 6. Subject is in good general health as determined by the Investigator on the basis of medical history.
• 7. Subjects is willing to maintain the test patches in designated positions for 24 Hours.
• 8. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• 10. Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
• 11. For Sensitive Specific Skin Study Only: • Subject scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin in modified Dr Baumann’s skin type questionnaire.
• • Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
test	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
To evaluate the dermatological safety of the	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
skin types (Oily, Dry, Normal and Combination)	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
product by 24 Hours Patch Test Under	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
Complete Occlusion on healthy adult human	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
subjects and adequate representation of	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)
varied	To evaluate the dermatological safety of the | test | product by 24 Hours Patch Test Under | Complete Occlusion on healthy adult human | subjects and adequate representation of | varied | skin types (Oily, Dry, Normal and Combination)

Secondary Outcome Measures

Name	Time	Method
To evaluate the Safety on the	skin

Trial Locations

Locations (1)

NovoBliss Research Private Limited; 🇮🇳 Ahmadabad, GUJARAT, India

NovoBliss Research Private Limited

🇮🇳Ahmadabad, GUJARAT, India

Dr Nayan Patel

Principal investigator

917948983895

dr.nayan@novobliss.in