Clinical trial NCT06578962: Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
Official title: Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Seborrheic
Keywords: Dermatitis, Seborrheic
Scalp
Adults
Maintenance of effects
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
timeFrame: Assessed after 8 weeks of use, during the maintenance phase
Secondary outcomes:
measure: Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator
timeFrame: Assessed at baseline and after 2, 6 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home
measure: Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator
timeFrame: assessed after 2, 6 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject
timeFrame: assessed weekly at home
measure: Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject
timeFrame: assessed at baseline and weekly at home
measure: Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples
timeFrame: assessed at baseline and after 2 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the analysis of Inflammatory marker evolution from scalp swab samples
timeFrame: assessed at baseline and after 2 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the analysis of prurit marker evolution from scalp swab samples
timeFrame: assessed at baseline and after 2 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the analysis of cellular cohesion proteins evolution from scalp swab samples
timeFrame: assessed at baseline and after 2 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the Metabolomic analysis from scalp swab samples
timeFrame: assessed at baseline and after 2 and 10 weeks of use
measure: Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use
measure: Compliance of the subjects to the test product RV3438G
timeFrame: through study completion, 10 weeks
measure: Tolerance of the test product RV3438G assessed by the investigator
timeFrame: assessed at baseline and after 2, 6 and 10 weeks of use
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Santé Sabouraud - Hôpital Saint Louis
Study officials:
affiliation: Centre de santé SABOURAUD - Hôpital Saint Louis
name: Pascal REYGAGNE, Dr
role: PRINCIPAL_INVESTIGATOR
References: