Skin Safety Study on Healthy Human Subjects with sensitive Skin

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009140

Enrollment

Registered

2017-07-27

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.Dabur Gulabari Premium Gulab Jal(036/P136) 2.Dabur Gulabari Premium Gulab Jal(036/P137) 3.Gulabari Rose Glow Lotion 4.Dadur Gulabari Moisturising cold cream 5.Gulabari Rose Glow Face

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects in age group 18 - 55 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. 9.Subjects with sensitive skin type as per the score obtained from the skin type identification questionnaire and by dermatological evaluation for the confirmation of the same.

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 study. 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
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin typeTimepoint: O hr, 24 hr, 7 days	—

Secondary

Measure	Time frame
Overall safety of SubjectsTimepoint: O hr, 24 hr, 7 days	—

Countries

India

Contacts

Public ContactRitambhara

Dabur India Limited

arun.gupta@dabur.com1204552645

Outcome results