MedTrace Logo

IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)

NCT05171556 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2021-12-29

No results posted yet for this study

Summary

The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use.

The aim of this study is also to:

* evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.
* evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm\*, D8 and D22.
* evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm\*, D8 and D22.
* evaluate the cosmetic acceptability by a questionnaire at D22.

This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin.

Timm\*: 10 to 30 minutes after first application

Conditions

  • Hypersensitive
  • Reactive and Intolerant Skin
  • Redness-prone Skin
  • Stinger Subjects

Interventions

OTHER

Cosmetic product

RV4942A is a face balm product

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Lexi LIU · EUROFINS CHINA

Eligibility

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

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2021-05-11
Completion
2021-05-11

Countries

  • China

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 NCT05171556 on ClinicalTrials.gov