Dermatological 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/2016/12/007514

Enrollment

Registered

2016-12-01

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. Olive Badam Baby Massage Oil 2. Aloederm Cream 3. Skinetics Moist Lotion 4. Keratex 5.Femite 6. Keratone Oil: Products will be evaluated through single application closed patch t

Eligibility

Inclusion criteria

Inclusion criteria: •Subjects in age group 18 -55 years •Healthy male & female subjects •Subjects with Fitzpatrick skin type IIIto V. •Subjects willing to give a written informed consent. •Subjects willing to maintain the patch test in position for 24 hours •Subject having not participated in a similar investigation in•the past two weeks. •Subjects willing to come for regular follow up visits. •Subjects ready to follow instructions during the study period. •Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-Iand by dermatological evaluation for the confirmation of the same.

Exclusion criteria

Exclusion criteria: •Infection, allergy on the tested area •Skin allergy antecedents or atopic subjects •Athletes and subjects with history of excessive sweating •Cutaneous disease which may influence the study result •Chronic illness which may influence the cutaneous state. •Subjects on oral corticosteroid more than 10 mg/day •Subjects participating in any other cosmetic or therapeutic study. •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
Over all safety of the subjectsTimepoint: 0 hr, 24 hr, 7 days	—

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results