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To check the safety of 3 test product for skin irritation

Evaluation of Skin Safety of 3 test products for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033206
Enrollment
60
Registered
2021-04-28
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: Aceclofenac, Menthol, Methyl Salicylate & Linseed Oil Gel (with Acrypol 980): 0.04 gm of test product will be applied on test site. Then it will be semi-occluded. Duration of occlusion

Sponsors

Lyka Labs Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fitzpatrick skin type III to IV. Having apparently healthy skin on test area. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.

Exclusion criteria

Exclusion criteria: Pregnancy (by history) and lactating women. Scars, excessive terminal hair or tattoo on the studied area. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye)

Design outcomes

Primary

MeasureTime frame
Evaluation of cutaneous tolerance by dermatological scoring of skin reactions using Draize scaleTimepoint: 48 hours—

Secondary

MeasureTime frame
NoneTimepoint: None—

Countries

India

Contacts

Public ContactMrs Shweta Daptardar

Lyka Labs Limited

rssamant@lykalabs.com9870224452

Outcome results

None listed

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