Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Seborrheic
• Intervention / Treatment: 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

Detailed Description

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 (Actual): 63

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Centre de Santé Sabouraud - Hôpital Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the panel of volunteers of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.

Description

Inclusion Criteria:

Criteria related to the population:

- Subject aged between 18 and 60 years included

Criteria related to the disease:

Subject having a squamous state of the scalp :

• clinically visible (Squire score ≥ 20),
• with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
• recurrent (at least twice a year)
• associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)

Exclusion Criteria:

Criteria related to the diseases / skin condition:

• Subject having frizzy hair
• Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment

Criteria related to treatments and/or products:

• Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
• Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
• Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: Phase 1: short intensive treatment phase; During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.; Other: Phase 2 : neutral shampoo; During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks.
Tested product RV3438G associated with gentle balancing shampoo	Other: Phase 1: short intensive treatment phase; During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.; Other: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo; 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.
Tested product RV3438G associated with neutral shampoo	Other: Phase 1: short intensive treatment phase; During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.; Other: Phase 2 : Tested product RV3438G associated with neutral shampoo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Pascal REYGAGNE, Dr, Centre de Santé Sabouraud - Hôpital Saint Louis

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Adults; Scalp; Dermatitis, Seborrheic; Maintenance of effects
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic
• Other Study ID Numbers: RV3438G2020043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No