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Primary Irritation Test on Humans with Normal Skin Type

To evaluate dermatological safety of investigational products by 24 hours patch test under complete occlusion on adult healthy human subjects with non-sensitive and sensitive skin - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036350
Enrollment
48
Registered
2021-09-08
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 Vatika Select Red Onion Black Seed Oil Shampoo 2. Dabur Vatika Select Apple Cider Vinegar Shampoo 3. Dabur Vatika Select Moroccan Argan Oil Shampoo 4. Dabur Vatika Select Cocon

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1 Specific: Subjects scoring less than or equal to 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire. Group 2 Specific: Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire. Common to Group 1 & 2: 1.Healthy male and female subjects (1:1 ratio) in the age group of 18-65 years (both age inclusive). 2.Subjects representing with normal, oily, dry and combination skin type in equal ratio. 3.Subjects with normal Fitzpatrick skin type III to V. 4.Female subjects with child bearing potential willing to undergo Urine Pregnancy Test. 5.Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results. 6.Subjects willing to give a voluntary written informed consent. 7.Subjects willing to maintain the patch test in position for 24 hours. 8.Subject having not participated in a similar investigation in the past two weeks. 9.Subjects willing to come for regular follow up visits. 10.Subjects ready to follow instructions during the study period

Exclusion criteria

Exclusion criteria: Common to Group 1 & 2: 1.Infection, allergy on the tested area. 2.Skin allergy antecedents or atopic subjects. 3.Subjects with known hypersensitivity to any of the study products or constituents. 4.Subjects with any significant skin pathology in the investigational area 5.Athletes and subjects with history of excessive sweating. 6.Cutaneous disease which may influence the study result. 7.Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study. 8.Subjects on oral corticosteroid. 9.Subjects participating in any other cosmetic or therapeutic study. 10.Female subjects who are pregnant or lactating. 11.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

MeasureTime frame
Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin type and sensitive Skin TypeTimepoint: 0 hr, 24 hr, 48 hr & 7 days

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactRitambhara

Dabur India Limited

sasibhushan.vedula@dabur.com01203378405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026