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TO EVALUATE THE SAFETY OF 4 TEST PRODUCTS -UNDER EYE CONCEALER, V WASH PLUS , TACROLIMUS SOLUTION AND LA SHIELD LITE SUNSCREEN GEL SPF 40, FOR PRIMARY SKIN IRRITATION USING PATCH TEST.

EVALUATION OF THE SKIN SAFETY OF 4 TEST PRODUCTS -UNDER EYE CONCEALER, V WASH PLUS (LACTIC ACID 1.2 % W/W), TACROLIMUS SOLUTION (0.1% w/v) AND LA SHIELD LITE SUNSCREEN GEL SPF 40, FOR PRIMARY SKIN IRRITATION USING A PATCH TEST.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/07/003813
Enrollment
35
Registered
2013-07-16
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: Under Eye Concealer: 0.04 ml or g (as applicable) of the test product, 3 will be filled in wells of Patch chambers and will be applied occlusively on upper arm of subjects at Hour 0. Du

Sponsors

Glenmark Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and/or women with sensitive skin between 18 and 65 years. 2. SLS responders determined by applying 3 % SLS patch on subjects. 3. Having apparently healthy skin on test area. 4. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study. 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives. 7.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study. 9. Ready to wear loose cotton clothes.

Exclusion criteria

Exclusion criteria: 1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc). 2. Pregnant women and lactating women (as confirmed by UPT) 3. Scars, excessive terminal hair or tattoo on the studied area. 4. A subject who the Investigator feels will not be compliant with trial requirements. 5. Dermatological infection/pathology on the level of studied area. 6. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material). 7. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 8. Subjects 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). 9. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

Design outcomes

Primary

MeasureTime frame
Dermatological evaluation of skin safety will be carried out post removal of patch at Visit 3(48 Hours)Timepoint: 48 hours

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Amit Bhargav

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