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Evaluation of the skin safety of 1 soap, for skin irritation using a patch test.

Evaluation of the skin safety of 1 soap, for primary skin irritation using a patch test.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009271
Enrollment
35
Registered
2017-08-04
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: Abzorb Syndet Bar Soap (1% Clotrimazole): At VISIT 1 (0 hrs): 8% w/w solution of the soap will be prepared. 40 microlitre (dose) of the test product (filter papers dipped in liquid prod

Sponsors

VVF India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Voluntary men and/or women between 18 and 65 years. • Having apparently healthy skin on test area. • Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study. • Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. • Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study. • Ready to wear loose cotton clothes.

Exclusion criteria

Exclusion criteria: • Pregnant women and lactating women (by history). • Scars, excessive terminal hair or tattoo on the studied area. • Dermatological infection/pathology on the level of studied area. • Hypersensitivity, allergy antecedent (to any cosmetic product, raw material). • Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. • Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).

Design outcomes

Primary

MeasureTime frame
Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hoursTimepoint: Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Vadiraj Ekkundi

C.L.A.I.M.S. PVT.LTD

rsjdr@rediffmail.com66758851

Outcome results

None listed

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