Seborrheic Dermatitis
Conditions
Keywords
seborrheic dermatitis, shampoo, squamous states, squire score, biological, samples, standard medical care, cosmetic product
Brief summary
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.
Detailed description
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)
Interventions
OTHERRV5263A - WS0060
Cosmetic product Thrice weekly applications
OTHERRV5263A - LC3302
Cosmetic product Thrice weekly applications
Standard medical care applications
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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: * clinically visible (Squire score ≥ 20), * recurrent (at least twice a year) * having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization * 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: * alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage\> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis) * raised skin lesion, likely to be traumatized, … * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dandruff severity (Squire score) after 29 days of product application | Visit 1 (Day 1) and Visit 6 (Day 29 or early termination). | Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22) | Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator |
| Intensity of squamous global state | 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) | Intensity of the squamous state on a 4-point scale (from 0 to 3), performed by the investigator |
| Irritation state score (erythema) | 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) | Erythema score on a 4-point scale (from 0 to 3), performed by the investigator |
| Irritation state score (pruritus) | 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) | Mean pruritus felt on the last 3 days on a NRS (0-10), performed by the subject |
| Irritation state score (burning sensation) | 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) | Burning sensation score, on a NRS (0-10), performed by the subject |
| Immediate irritation state score (pruritus) | Immediately after the 1st application of product | Immediate pruritus felt, on a NRS (0-10), performed by the subject |
| Immediate irritation state score (burning sensation) | Immediately after the 1st application of product | Immediate burning sensation score, on a NRS (0-10), performed by the subject |
| Investigator Global Assessment | Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination) | Investigator Global Assessment, on a 5-point scale (from 1 to 5), performed by the investigator |
| Subject Global Assessment | 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, on a 5-point scale (from 1 to 5), performed by the subject |
| Evolution of squamous state (dandruff) | 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) | Squamous state (dandruff) score, on a 4-point scale, (from 0 to 3), performed by the subject |
| Evolution of discomfort | 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) | Discomfort evolution, on a 4-point scale (from 0 to 3), performed by the subject |
| Quality of Life, specific scalp questionnaire | Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination) | Scalpdex questionnaire, completed by the subject |
| Quality of life, Chronic Itch Burden scale | 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) | Chronic Itch Burden questionnaire, completed by the subject |
| Acceptability Questionnaire assessment | Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination) | Acceptability questionnaire regarding the use of the product will be completed by the subject. |
| Recording of adverse events | From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination) | Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation |
| Illustration of subject's squamous state evolution | 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) | Standardized photographs of the subject's scalp of affected area for illustrative purpose only |
| Strains of the scalp microbiota | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15) | Via cotton-swab sampling |
| Scalp proteic markers | Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15) | via cotton-swab sampling |
| Molecular characterization of the scalp sebum | 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) | via cigarette paper sampling |
| Molecular characterization of the scalp - lipids | 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) | via cigarette paper sampling |
Countries
Poland
Outcome results
None listed