To check the Safety of the produts

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047902

Enrollment

Registered

2022-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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. Golden years face serum (R&D/PL/FS-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Mic

Frequency- once during the study period

Route of administration- Topical

Duration: 9 days for each subject Intervention2: 2. Cerabuild face and neck cream (R&D/PL/NC-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applie

Duration: 9 days for each subject Intervention3: 3. Ice-bath face mist (R&D/PL/RM-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side

Duration: 9 days for each subject Intervention4: 4. Poreslay face serum (R&D/PL/PFS-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back si

Duration: 9 days for each subject Intervention5: 5. Smooth-sorbet oil-free face gel creme (R&D/PL/OFG-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will

Duration: 9 days for each subject Intervention6: 6. Blavana Body Lotion (R&D/PL/BL-01): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back sid

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 as defined in the population details. 3. 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. 4. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 5. Subjects willing to give a voluntary written informed consent. 6. Subjects willing to maintain the patch test in position for 24 hours. 7. Subject having not participated in a similar investigation in the past two weeks. 8. Subjects willing to come for regular follow up visits. 9. 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
To determine the potential irritation of the test formulation on topical application in skin type human volunteers under controlled patch study conditions in a PIPT test.Timepoint: Approximately 9 days.	—

Secondary

Measure	Time frame
NoneTimepoint: NA	—

Countries

India

Contacts

Public ContactRadha S

Transformative Learning Solution Pvt. Ltd.

satyendra.kumar@transformative.in9891253516

Outcome results