To determine the safety of the test products.

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. - None

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/033199

Enrollment

Registered

2021-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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. Cream (130041 SAA HCC): 40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microliter

Frequency- once during the study period

Route of administration- Topical

Duration: 9 days for each subject Intervention2: 2. Cream (130042 SAA APC): 40 microliter of investigational product with or without dilution (as per the protocol) will be applied back side of the sub

Duration: 9 days for each subject Control Intervention1: 3.Negative control(0.9N Saline): 40 microliter of Negative control (0.9N Saline) will be applied on the back side of the subject along with the

Duration: 9 days for each subject Control Intervention2: 4. Positive control(1% SLS): 40 microliter of Positive control (1% SLS) will be applied on the back side of the subject along with the test pro

Duration: 9 days for each subject

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects in age group 18 - 65 years (both the ages inclusive). 2.Healthy male & female subjects. 3.Subjects with Fitzpatrick skin type III to V. 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.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.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

Measure	Time frame
To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: Approximately 9 days for each subject.	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@mscr.in08041125934

Outcome results