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Completed

NCT Number: NCT06578962

Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Santé Sabouraud - Hôpital Saint Louis

Paris, 75010, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Phase 2 : neutral shampoo

Other

During maintenance phase (phase 2):

the neutral shampoo RD0057H was applied thrice a week for 8 weeks.

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

    Time frame: Assessed after 8 weeks of use, during the maintenance phase

    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

Secondary outcomes

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

    Time frame: Assessed at baseline and after 2, 6 and 10 weeks of use

    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

  2. Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use

    assessed by the investigator on the scalp on a 4-point scale (from absent to severe)

  3. Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home

    assessed by the subject on the scalp on a 10-point scale (from absent to maximal severity)

  4. Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator

    Time frame: assessed after 2, 6 and 10 weeks of use

    assessed by the investigator on the scalp on a 5-point scale (from worsening to complete resolution)

  5. Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject

    Time frame: assessed weekly at home

    assessed by the subject on the scalp on a 5-point scale (from worsening to complete resolution)

  6. Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use

    assessed by the subject on the scalp on a 4-point scale (from absent to severe)

  7. Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject

    Time frame: assessed at baseline and weekly at home

    assessed by the subject on the scalp on a 4-point scale (from absent to severe)

  8. Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples

    Time frame: assessed at baseline and after 2 and 10 weeks of use

    Microbiota diversity is analyzed by 16S and ITS1 sequencing.

  9. Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use

    Microbiota composition is analyzed by ddPCR of some fungal and bacterial species

  10. 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

  11. 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

  12. 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

  13. 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

  14. Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use

    Assessed by FTIR analysis

  15. Compliance of the subjects to the test product RV3438G

    Time frame: through study completion, 10 weeks

    The subject will report his/her compliance in a subject's diary

  16. Tolerance of the test product RV3438G assessed by the investigator

    Time frame: assessed at baseline and after 2, 6 and 10 weeks of use

    Determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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