Last reviewed · How we verify

NCT05171556

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

Completed Last updated 29 December 2021
What this trial tests

trial testing Cosmetic product in Hypersensitive in 33 participants. Completed in 11 May 2021.

Timeline
20 April 2021
Primary endpoint
11 May 2021
11 May 2021

Quick facts

Lead sponsorPierre Fabre Dermo Cosmetique
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date20 April 2021
Primary completion11 May 2021
Estimated completion11 May 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Pierre Fabre Dermo Cosmetique — full company profile →

Who can join

Adults 18 to 65, any sex, with Hypersensitive or Reactive and Intolerant Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Cosmetic product

Trials testing the same drug.

Other Pierre Fabre Dermo Cosmetique trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05171556.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing