Safety evaluation of test products within 24 hours on skin.

Not Applicable

Completed

• Registration Number: CTRI/2022/01/039071
• Lead Sponsor: Vasu Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-04
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Voluntary men and women ration of 1:1 between 18 and 65 years.

Having healthy skin on test area as assessed by dermatological examination.

For whom the investigator considers that the compliance will be correct.

Subjects with normal, dry, oily and combination skin

Subjects cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.

Having a signed consent form.

Subjectsââ?¬• willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.

Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna �.), during the study.

Having valid proof of identity and age.

Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

Exclusion Criteria

Pregnant/nursing mothers.

Scars, excessive terminal hair, or tattoo on the studied area.

Dermatological infection/pathology on 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 treatment or procedures.

ââ???Chronic illness which may influence the outcome of the study.

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).

Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.

Volunteers evaluated with Fitzpatrick skin type 1,2 and 6 as per the Fitzpatrick scale (Appendix IV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of subjects that showed No significant irritation. <br/ ><br> Score of less than or equal to 2 on the Draize scale. <br/ ><br>Timepoint: Day0,Day1,Day2, Day3, Day4, Day5

Secondary Outcome Measures

Name	Time	Method
/ATimepoint: N/A