To Check Dermatological Safety of Test Products by 24 Hours Patch Test under CompleteOcclusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects
- Registration Number
- CTRI/2023/04/051801
- Lead Sponsor
- Mohrish Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
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 01 prior to patch application.
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. The subject is in good general health as
determined by the Investigator on the basis of medical history.
7. Subjects are 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. The 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 instructions given.
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)
10. Topical drugs used at application site.
11. Subject with Self-reported Immunological disorders such as HIV
positive, AIDS and/or systemic lupus erythematous.
12. Individual who has a medical condition or is taking or has taken a
medication which, in the Investigatorâ??s judgment, makes the subject
ineligible or places the subject at undue risk.
13. Subject with known allergy or sensitization to medical adhesives,
bandages.
14. 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 <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)Timepoint: Irritation Scoring at 30 mins and 24 hours post <br/ ><br>patch removal. Scoring can be done at 168 <br/ ><br>hours post-patch removal if needed.
- Secondary Outcome Measures
Name Time Method Safety of the skinTimepoint: At 30 mins and 24 hours post patch removal. <br/ ><br>Scoring can be done at 168 hours post-patch <br/ ><br>removal if needed