Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
NCT Number: NCT06578962
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dermatitis, Seborrheic
Interventions: OTHER: Phase 1: short intensive treatment phase|OTHER: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo|OTHER: Phase 2 : Tested product RV3438G associated with neutral shampoo|OTHER: Phase 2 : neutral shampoo
Sponsor: Pierre Fabre Dermo Cosmetique
Sex: ALL
Age: ADULT
Enrollment: 63
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-11-09
Completion Date: 2021-05-11
Locations: Centre de Santé Sabouraud - Hôpital Saint Louis, Paris, 75010, France

Summary:
The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.

This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.

4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.

The study area is the whole scalp.

Primary Outcome Measures: Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator, Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp, Assessed after 8 weeks of use, during the maintenance phase
Secondary Outcome Measures: Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator, Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp, Assessed at baseline and after 2, 6 and 10 weeks of use|Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator, assessed by the investigator on the scalp on a 4-point scale (from absent to severe), assessed at baseline and after 2, 6 and 10 weeks of use|Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject, assessed by the subject on the scalp on a 10-point scale (from absent to maximal severity), assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home|Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator, assessed by the investigator on the scalp on a 5-point scale (from worsening to complete resolution), assessed after 2, 6 and 10 weeks of use|Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject, assessed by the subject on the scalp on a 5-point scale (from worsening to complete resolution), assessed weekly at home|Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject, assessed by the subject on the scalp on a 4-point scale (from absent to severe), assessed at baseline and after 2, 6 and 10 weeks of use|Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject, assessed by the subject on the scalp on a 4-point scale (from absent to severe), assessed at baseline and weekly at home|Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples, Microbiota diversity is analyzed by 16S and ITS1 sequencing., assessed at baseline and after 2 and 10 weeks of use|Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples, Microbiota composition is analyzed by ddPCR of some fungal and bacterial species, assessed at baseline and after 2, 6 and 10 weeks of use|Efficacy of the test product RV3438G by the analysis of Inflammatory marker evolution from scalp swab samples, assessed at baseline and after 2 and 10 weeks of use|Efficacy of the test product RV3438G by the analysis of prurit marker evolution from scalp swab samples, assessed at baseline and after 2 and 10 weeks of use|Efficacy of the test product RV3438G by the analysis of cellular cohesion proteins evolution from scalp swab samples, assessed at baseline and after 2 and 10 weeks of use|Efficacy of the test product RV3438G by the Metabolomic analysis from scalp swab samples, assessed at baseline and after 2 and 10 weeks of use|Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample, Assessed by FTIR analysis, assessed at baseline and after 2, 6 and 10 weeks of use|Compliance of the subjects to the test product RV3438G, The subject will report his/her compliance in a subject's diary, through study completion, 10 weeks|Tolerance of the test product RV3438G assessed by the investigator, Determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation, assessed at baseline and after 2, 6 and 10 weeks of use