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Safety testing of cosmetic products through patch test

Evaluation of dermatological safety of Investigational products by primary irritation Patch test on subjects with sensitive skin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009503
Enrollment
35
Registered
2017-08-28
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: 1)Skin Leave On 2)Skin Leave On 3)Skin Leave On 4)Rinse Off 5)RInse Off 6)Skin Leave- On (Perfume) 7)Skin Leave- On (Perfume) 8)Skin Leave- On (Perfume) 9)Skin Leave- On (Perfume) 10)Sk

Sponsors

ITC Limited ITC Life Sciences Technology Centre
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)Subjects in good general health 3)Subjects with Fitzpatrick skin phototype III to V 4)Subjects scoring greater than 30 for section 2- sensitive v/s resistant skin in modified Dr. Baumannââ?¬•s skin type questionnaire 5)Subject identified to have sensitive skin basis dermatologistââ?¬•s assessment of skin with fine texture and closeness of blood vessels to the surface 6)Subjects willing to give a voluntary written informed consent 7) Subjects willing to maintain the test patches in designated positions for 24 hours 8)Subjects willing to come for regular follow up visits 9)Subjects ready to follow instructions during the study period 10) Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results

Exclusion criteria

Exclusion criteria: 1) Subjects with a present condition of allergic response to any cosmetic product on the test area 2)Subjects under chronic medication (e.g. antihistamines, antifungals, corticosteroids, topical steroids, etc.) that might influence the outcome of the study 3)Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy) 4) Subjects suffering from any cutaneous disease that could interfere with the study results 5) Subjects suffering from any chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness 6) Subjects participating in any other cosmetic or therapeutic trial 7) Subjects having participated in a similar investigation in the past four weeks

Design outcomes

Primary

MeasureTime frame
Safety assessment of investigational products for irritational potential using Draize scoreTimepoint: Draize Scoring to be done at 0 hrs, 24 hrs and day 7 of patch removal

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDeepika Arora

CIDP Biotech India Pvt. Ltd

a.jain@cidp-cro.com09582645711

Outcome results

None listed

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