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Safety testing of cosmetic products by patch test

Evaluation of dermatological safety of test products by primary irritation patch test on healthy human volunteers of varied skin types

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038813
Enrollment
24
Registered
2021-12-21
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

Intervention1: Number of total products are 18 (Shampoo, Cream, Serum, Lotion, Gel, Oil): Approximately 40 �µl of each product are dispensed in the aluminium chambers of the patch and applied on the

Sponsors

Arbro pharmaceutical Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy male and female subjects in the age group of 18-55 years(both age inclusive) 2. Subject is having valid proof of identity and age 3. Subjects with skin phototype III to V 4.Subject is having apparently healthy skin on test area 5.Subject representing normal, oily, dry and combination skin type in nearly equal ratio 6. Subject willing to give a voluntary written informed consent 7. Subject willing to maintain the test patches in designated positions for 24 Hours 8. Subject willing to come for regular follow up visits 9. Subject ready to follow instructions during the study period 10. Subject without any open wounds, cuts, abrasions, irritation symptoms

Exclusion criteria

Exclusion criteria: 1. Subjects with Known hypersensitivity to any of the study products or constituents 2. Subjects having any significant pathology in the test area 3. Subjects with any kind of skin allergy, antecedents or cutaneous disease which may influence the study results 4. Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments 5. Athletes and subjects with history of excessive sweating 6. Subject is Pregnant or Lactating 7. Subject with any significant medical condition that would interfere with the participation in the trial 8. Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation 9. Subject is having Scars, excessive terminal hair or tattoo on the studied area

Design outcomes

Primary

MeasureTime frame
Safety assessment of investigational products for irritation potential using Draize scale after patch removal at 0 hours(day 3),24 hours(day 4) and 7 days post patch removal.Timepoint: Safety assessment of investigational products for irritation potential using Draize scale at 0 hours,24 hours and 7 days post patch removal.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactPurushotam

Auriga Research Pvt. Ltd.

manojkarwa@aurigaresearch.com0124006445

Outcome results

None listed

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