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Skin Safety Study on Healthy Human Subjects

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
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009257
Enrollment
24
Registered
2017-08-03
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: Product 1- La! Tail Product 2- Badam Tail Product 3- Shila X Tail Product 4- Mahanarayan Tail Product 5- Maha Bhingraj Tail Product 6- Rheumatil Gel : Study will be conducted over a per

Sponsors

Dabur India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Subjects in age group 18 -55 years 2 Healthy male and female subjects 3 Subjects with Fitzpatrick skin type III to V. 4 Subjects willing to give a 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 on the skin type identification questionnaire in annexure-I and 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 •Hyper sensitivity to any component of the tested products •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 •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

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

Secondary

MeasureTime frame
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin typeTimepoint: 9 days

Countries

India

Contacts

Public ContactDr Arun Gupta

MS Clinical Research Pvt. Ltd,

mukesh.ramnane@mscr.in9844020353

Outcome results

None listed

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