Patch testing

Completed

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

• Registration Number: CTRI/2020/12/029938
• Lead Sponsor: Vasu Research Centre

Brief Summary

Todetermine the potential of the test articles to cause cutaneous irritation inadult human subjects after single 24-hour occluded patch application.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-27
• Study Completion: 2020-12-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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 numbers of males and females).
• 3)Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
• 4)Subject who does not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• 5)Subject is in good general health as determined by the Investigator on the basis of medical history.
• 6)Subject willing to maintain the test patches in designated positions for 24 Hours.
• 7)Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• 9)Subject is willing to refrain from vigorous physical exercise during the study period.

Exclusion Criteria

• 1)Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, 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 with history of diabetes.
• 4)Subject with 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 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.
• 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 article 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, 24 hours and 168 hours

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 Nayan Patel

Principal investigator

9909013286

nkpatel@cliantha.com