To check dermatological safety of test products by 24 hours patch test on adult healthy human subjects

Not Applicable

• Registration Number: CTRI/2024/06/069652
• Lead Sponsor: Kayura Effect LLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Age: 18-65 years (both inclusive) at the time of consent.

2)Sex: Males and non-pregnant/non-lactating females (preferably an

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.

9)Subject must be able to understand and provide written informed

consent to participate in the study.

10) 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.

6) Subject having history of any skin diseases including eczema,

atopic dermatitis or active cancer.

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) 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the test <br/ ><br>products by 24 Hours Patch Test Under <br/ ><br>Complete Occlusion on healthy adult human <br/ ><br>subjects and adequate representation of varied <br/ ><br>skin types (Oily, Dry, Normal and Combination) <br/ ><br>Timepoint: post patch removal at 30 min, 24 hours and 168 hours <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To evaluate the Safety of the skinTimepoint: Remove the patch 30 minutes after application on Day 01 & at 24 hours on Day 02. Scoring can be performed 168 hours (Day 08) after patch removal.