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To study the effect of 2 products (topical anaesthesia) and any unwanted side-effect (if any)

Evaluation and comparison of the local anaesthetic effect of 2 Products, when applied topically and the in-use tolerance of Products

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021212
Enrollment
26
Registered
2019-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Xylap Cream: 1gm will be applied topically on skin. Application will be done only once. Control Intervention1: Prilox Cream: 1gm will be applied topically on skin. Application will be

Sponsors

Bliss GVS Pharma Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy skin on test area Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas 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. A participant who the Investigator feels will not be compliant with study requirements. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material). Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.

Design outcomes

Primary

MeasureTime frame
Grading of the anaesthetic effect by participants using a Scale [0 â?? 3]Timepoint: 0 hours 30 mins 45 mins 60 mins—

Secondary

MeasureTime frame
Evaluation of redness of skin using skin color measuring instrumentTimepoint: 0 hours 30 mins 45 mins 60 mins;Measurement of fluid content in the deeper layers of skin by MoistureMeter DTimepoint: 0 hours 30 mins 45 mins 60 mins—

Countries

India

Contacts

Public ContactDr Amolkumar Lokhande

Bliss GVS Pharma Ltd

clinical@blissgvs.com02242160000

Outcome results

None listed

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