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Dermatological Safety Study on Healthy Human Subjects

Evaluation of skin sensitivity of Pure Hands Advanced manufactured by M/s. Himalaya Drug Company Bangalore L/L @ M/s. Ador Multiproduts Ltd., Puducherry by 24hrs patch test under complete occlusion on healthy human subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038144
Enrollment
24
Registered
2021-11-18
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

None listed

Sponsors

ADOR MULTIPRODUCTS LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in age group 18 - 55 years (both the ages inclusive). 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 one months. 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. Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment 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

MeasureTime frame
To assess the Erythema and Oedema (Draize scale) as per IS4011: 2018 by 24 hr patch under occlusionTimepoint: 0 hr, 24 hr, 48 hr and 7 days

Secondary

MeasureTime frame
To assess the adverse eventsTimepoint: 0 hr, 24 hr, 48 hr and 7 days

Countries

India

Contacts

Public ContactDr Anand Sachdeva

Rajalakshmi Hospital

rajalakshmi.derma@gmail.com

Outcome results

None listed

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