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The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of seborrheic dermatitis.
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
A total number of 90 subjects included and randomized in 3 parallel groups:
Test group RV5263A - WS0060 cosmetic product
Comparative group: RV5263A - LC3302 cosmetic product
Standard medical care group
6 visits are planned:
Visit 1: Inclusion (Day 1)
Visit 2: Intermediate visit (Day 4)
Visit 3: Intermediate visit (Day 7)
Visit 4: Intermediate visit (Day 15 ± 1 day)
Visit 5: Intermediate visit (Day 22 ± 3 days)
Visit 6: End-of-study visit (Day 29 ± 3 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental |
| |
| Comparative group | Other |
| |
| Standard medical care group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV5263A - WS0060 | Other | Cosmetic product Thrice weekly applications |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dandruff severity (Squire score) after 29 days of product application | Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator | Visit 1 (Day 1) and Visit 6 (Day 29 or early termination). |
| Measure | Description | Time Frame |
|---|---|---|
| Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application | Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22) |
| Intensity of squamous global state |
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Inclusion Criteria:
Male or Female aged between 18 and 70 years included
Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
Subject having a squamous state of the scalp:
Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
Subject having a maximum usual shampoo frequency of 3/week
Non Inclusion criteria
Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:
Subject having dermatological pathology or evolutive skin lesion on the scalp (contact dermatitis, psoriasis, severe excoriations, severe sunburn, cutaneous bacterial superinfection of the scalp clinically obvious ...)
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 (including henna), bleaching, perm, smoothing / straightening performed within 3 weeks before inclusion or planned during the study
Any topical hair product (conditioner, serum, mask, gel, lacquer, wax, foam…) or water applied on the scalp between the last shampoo and the inclusion visit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. E.Karamon Private Practice | Malbork | Poland | 82200 | Poland |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| RV5263A - LC3302 |
| Other |
Cosmetic product Thrice weekly applications |
|
| Standard Medical Care (SMC) | Drug | Standard medical care applications |
|
Intensity of the squamous state on a 4-point scale (from 0 to 3), performed by the investigator |
| Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Irritation state score (erythema) | Erythema score on a 4-point scale (from 0 to 3), performed by the investigator | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Irritation state score (pruritus) | Mean pruritus felt on the last 3 days on a NRS (0-10), performed by the subject | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Irritation state score (burning sensation) | Burning sensation score, on a NRS (0-10), performed by the subject | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Immediate irritation state score (pruritus) | Immediate pruritus felt, on a NRS (0-10), performed by the subject | Immediately after the 1st application of product |
| Immediate irritation state score (burning sensation) | Immediate burning sensation score, on a NRS (0-10), performed by the subject | Immediately after the 1st application of product |
| Investigator Global Assessment | Investigator Global Assessment, on a 5-point scale (from 1 to 5), performed by the investigator | Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Subject Global Assessment | Subject Global Assessment, on a 5-point scale (from 1 to 5), performed by the subject | Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Evolution of squamous state (dandruff) | Squamous state (dandruff) score, on a 4-point scale, (from 0 to 3), performed by the subject | Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Evolution of discomfort | Discomfort evolution, on a 4-point scale (from 0 to 3), performed by the subject | Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Quality of Life, specific scalp questionnaire | Scalpdex questionnaire, completed by the subject | Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination) |
| Quality of life, Chronic Itch Burden scale | Chronic Itch Burden questionnaire, completed by the subject | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Acceptability Questionnaire assessment | Acceptability questionnaire regarding the use of the product will be completed by the subject. | Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination) |
| Recording of adverse events | Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation | From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination) |
| Illustration of subject's squamous state evolution | Standardized photographs of the subject's scalp of affected area for illustrative purpose only | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Strains of the scalp microbiota | Via cotton-swab sampling | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15) |
| Scalp proteic markers | via cotton-swab sampling | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15) |
| Molecular characterization of the scalp sebum | via cigarette paper sampling | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| Molecular characterization of the scalp - lipids | via cigarette paper sampling | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) |
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |