Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

NCT06578962 | Completed

• 1 other identifier: RV3438G2020043
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Seborrheic

Keywords

Dermatitis, Seborrheic; Scalp; Adults; Maintenance of effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator

  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 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 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 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 weekly at home

Study Arms (3)

Tested product RV3438G associated with gentle balancing shampoo

Other: Phase 1: short intensive treatment phase; Other: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo

Tested product RV3438G associated with neutral shampoo

Other: Phase 1: short intensive treatment phase; Other: Phase 2 : Tested product RV3438G associated with neutral shampoo

Control group

Other: Phase 1: short intensive treatment phase; Other: Phase 2 : neutral shampoo

Interventions

Phase 1: short intensive treatment phase OTHER

During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.

Control group; Tested product RV3438G associated with gentle balancing shampoo; Tested product RV3438G associated with neutral shampoo

Phase 2 : Tested product RV3438G associated with gentle balancing shampoo OTHER

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 gentle balancing shampoo

Phase 2 : Tested product RV3438G associated with neutral shampoo OTHER

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.

Tested product RV3438G associated with neutral shampoo

Phase 2 : neutral shampoo OTHER

During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Centre de Santé Sabouraud - Hôpital Saint Louis

Paris, 75010, France

Location

Related Publications (1)

• Maitre M, Baradat S, Froliger M, Turlier V, Simcic-Mori A, Gravier E, Genies C, Lauze C, Huyghe C, Noustens A, Alvarez-Georges S, Marinescu R, Reygagne P, Bessou-Touya S, Mengeaud V, Duplan H. Scalp Microbiome Dynamics Can Contribute to the Clinical Effect of a Novel Antiseborrheic Dermatitis Shampoo Containing Patented Antifungal Actives: A Randomized Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2077-2097. doi: 10.1007/s13555-025-01408-z. Epub 2025 Jun 11.

  PMID: 40498389 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Swab sampling of the scalp and cigarette paper sample on the target lesions

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Pascal REYGAGNE, Dr

  Centre de santé SABOURAUD - Hôpital Saint Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: August 30, 2024
• Study Start: November 9, 2020
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)