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Primary Irritation Patch test on Humans with Sensitive Skin.

Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Non-Sensitive and Sensitive Skin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024200
Enrollment
24
Registered
2020-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 1. Odomos Naturals Non- Sticky Mosquito Repellent Cream 2. Odomos Naturals Mosquito Repellent Gel 3. Odomos Naturals Mosquito Repellent Lotion 4. Odomos Naturals Mosquito Repellent Spra

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire 2. Age 18-65 years at the time of consent . 3. Males and non-pregnant/non-lactating females (preferably equal number of males and females). 4. Subject with normal Fitzpatrick skin type III to V. 5. Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 6. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 7. Subject is in good general health as determined by the Investigator on the basis of medical history. 8. Subjects willing to maintain the test patches in designated positions for 24 Hours. 9. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 10. Subject must be able to understand and provide written informed consent to participate in the study. 11. Subject is willing to refrain from vigorous physical exercise during the study period.

Exclusion criteria

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, ab 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. Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous. 10. 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. 11. Subject with known allergy or sensitization to medical adhesives, bandages. 12. Participation in other patch study simultaneously. 13. 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) iv. Topical drugs used at application siterasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.

Design outcomes

Primary

MeasureTime frame
Safety assessment of productsTimepoint: 24 hours

Secondary

MeasureTime frame
Safety Assessment of ProductTimepoint: Baseline, 0 hour and 07 Days

Countries

India

Contacts

Public ContactMs Maheshvari Patel

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026