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To check is the test product is causing irritation or allergy in men/women after repeated applications of patch.

Evaluation of the Skin irritation and skin sensitization potential (Allergenicity) of a test product using Human Repeat Insult Patch Test (HRIPT). IS 4011:2018 Guidelines.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033208
Enrollment
240
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: Female who is pregnant by UPT or lactating. 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 scoringTimepoint: Visit 3 Visit 5 Visit 7 Visit 9 Visit 11 Visit 13 Visit 15 Visit 17 Visit 19—

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