Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-05-11

Brief Summary

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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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Detailed Description

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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

Conditions

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Dermatitis, Seborrheic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tested product RV3438G associated with gentle balancing shampoo

Phase 1: short intensive treatment phase

Intervention Type 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

Intervention Type 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 neutral shampoo

Phase 1: short intensive treatment phase

Intervention Type 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 neutral shampoo

Intervention Type 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.

Control group

Phase 1: short intensive treatment phase

Intervention Type 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 : neutral shampoo

Intervention Type OTHER

During maintenance phase (phase 2):

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Phase 2 : neutral shampoo

During maintenance phase (phase 2):

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No