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To check the safety of the products

Evaluation of dermatological safety of investigational products by cumulative irritancy test for 14 days under complete occlusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041526
Enrollment
30
Registered
2022-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

None listed

Interventions

Route of administration- Topical
Duration: 15 days for each subject Intervention2: 2.RM.M480.74: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention3: 3.RM.M480.76: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention4: 4.RM.M480.70: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention5: 5.RM.M480.81: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention6: 6.RM.M480.77: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention7: 7.RM.M480.85: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 15 days for each subject Intervention8: 8.RM.M480.86: 40 µl of investigational product with or without dilution (as per the protocol) wil

Sponsors

Marico Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female subjects with skin types normal, dry, oily, combination and sensitive skin type in equal ratio. 3. Subjects with Fitzpatrick skin type III to V. 4. Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. 5. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 6. Subjects willing to give a voluntary written informed consent. 7. Subjects willing to maintain the patch test in position for 22-24 hours as instructed. 8. Subjects willing not to apply any topical product at the test site for the entire study durations. 9. Subjects willing to refrain the test sites from direct sun light 10. Subject having not participated in a similar investigation in the past two weeks. 11. Subjects willing to come for regular follow up visits. 12. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Infection, allergy on the tested area. 2. Skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Cutaneous disease which may influence the study result. 5. Subjects on oral corticosteroid. 6. Subjects participating in any other cosmetic or therapeutic trial. 7. Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study. 8. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 9. More than one subject selected/participating from one family/household. 10. Subjects working with either MSCR or the sponsor.

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: Approximately 14 days for each subject

Secondary

MeasureTime frame
NoneTimepoint: NA

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt Ltd

ritambhara@mscr.in08041125934

Outcome results

None listed

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