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.
4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase
Study Type
OBSERVATIONAL
Enrollment
63
During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.
During maintenance phase (phase 2): the tested product RV3438G was applied once a week for 8 weeks the gentle balancing shampoo RD1089O was applied twice a week alternately with the RV3438G shampoo, for 8 weeks.
During maintenance phase (phase 2): the tested product RV3438G was applied once a week for 8 weeks the neutral shampoo RD0057H was applied twice a week alternately with the RV3438G shampoo, for 8 weeks.
During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks.
Centre de Santé Sabouraud - Hôpital Saint Louis
Paris, France
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
Time frame: Assessed after 8 weeks of use, during the maintenance phase
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
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