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To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects.

NCT06631898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-02-28

No results posted yet for this study

Summary

This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test\& Modified Dr baumenn's skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application \& 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)

Conditions

  • Normal Skin

Interventions

OTHER

SaaTwae Bio-Natural Moisturizing Cream

A 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.

Sponsors & Collaborators

  • Blossom Microbiotics LLC

    collaborator OTHER

  • NovoBliss Research Pvt Ltd

    lead OTHER

Principal Investigators

  • Dr. Nayan K Patel · NovoBliss Research Pvt Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2024-10-11
Completion
2024-10-17

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631898 on ClinicalTrials.gov