Safety of the test products to be checked.

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects of varied skin types. - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057621

Enrollment

Registered

2023-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

None listed

Interventions

Intervention1: 13-071A: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre

Frequency- once during the study period

Route of administration- Topical

Duration: 9 days for each subject Intervention2: 13-071C: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Mic

Duration: 9 days for each subject Intervention3: 13-071E: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Mic

Duration: 9 days for each subject Intervention4: 13-071G: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Mic

Duration: 9 days for each subject Intervention5: 15-094: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr

Duration: 9 days for each subject Intervention6: 141-105A: 40 microlitre of Investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Mi

Duration: 9 days for each subject Intervention7: 141-105B: 40 microlitre of Investigational product with or without dilution (as p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with Fitzpatrick skin type III to V 2. 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. 3. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 4. Subjects willing to give a voluntary written informed consent. 5. Subjects willing to maintain the patch test in position for 24 hours. 6. Subject having not participated in a similar investigation in the past two weeks. 7. Subjects willing to come for regular follow up visits. 8. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Subjects with infection, allergy on the tested area. 2. Subjects with skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Subjects with 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. Subjects with 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 MSCR

Design outcomes

Primary

Measure	Time frame
Dermatological safety of the investigational productsTimepoint: 0 hr, 24 hr and 7 day	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Navya Annam

MS Clinical Research

navya.annam@msclinical.com08041125934

Outcome results