Dandruff
Conditions
Keywords
Squamous, Malassezia, bacteria
Brief summary
A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota.
Interventions
OTHERdermatological product
cosmetic shampoo
Sponsors
L'Oreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
To evaluate the impact of an anti-dandruff shampoo compared to vehicle (placebo) on scalp microflora composition after 4 weeks of treatment and 4 weeks of relapse, on healthy volunteers with moderate to severe dandruff status
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female volunteers; 2. Age: 18 to 60 years old included; 3. Phototype (Fitzpatrick): I to IV; 4. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length; 5. Females of childbearing potential, who are sexually actives, using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study; 6. Subjects exhibiting moderate to severe dandruff status of scalp at screening 7. Subjects having at inclusion visit Day 0: 8. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10); 9. adherent dandruff score \> or = 2.5 (ranging from 0 to 5); 10. no limit for non-adherent dandruff score; 11. Subjects having on inclusion Day 0, 2 areas with dandruff (score \> 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score \< 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible 12. Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study; 13. Subjects agreeing to use only the supplied shampoo during all the study; 14. Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs); 15. Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling) 16. Subjects who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form. 17. Subject affiliated to a social security or insurance system; 18. Subjects willing to comply to the study requirements; 19. Subjects who are willing not to take part in another clinical study in another investigating centre; 20. Subjects who agree to give accurate personal information; 21. Subjects who are able to attend all study visits. \* The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion criteria
Inclusion Criteria 1. Healthy male or female volunteers; 2. Age: 18 to 60 years old included; 3. Phototype (Fitzpatrick): I to IV; 4. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length; 5. Females of childbearing potential, who are sexually actives, using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study; 6. Subjects exhibiting moderate to severe dandruff status of scalp at screening and at D-3; 7. Subjects having at inclusion visit Day 0: 8. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10); 9. adherent dandruff score \> or = 2.5 (ranging from 0 to 5); 10. no limit for non-adherent dandruff score; 11. Subjects having on inclusion Day 0, 2 areas with dandruff (score \> 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score \< 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible 12. Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study; 13. Subjects agreeing to use only the supplied shampoo during all the study; 14. Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs); 15. Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling) 16. Subjects who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form. 17. Subject affiliated to a social security or insurance system; 18. Subjects willing to comply to the study requirements; 19. Subjects who are willing not to take part in another clinical study in another investigating centre; 20. Subjects who agree to give accurate personal information; 21. Subjects who are able to attend all study visits. \* The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of microflora from swabs for fungi quantification | 1 month | malassezia qPCR |
| Analysis of microflora from swabs for fungi diversity | 1 month | sequencing ITS |
| Analysis of microflora from swabs for bacteria diversity | 1 month | sequencing 16S |
| Analysis of microflora from swabs for bacteria quantification | 1 month | Cutibacterium qPCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grading of Dandruff severity | 1 month | Dandruff severity 0-5 ordinal scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment of oily aspect of the scalp | 1 month | oily aspect of the scalp 1-5 ordinal scale |
| Self-perception of efficacy global efficacy | 1 month | Self-perception of global efficacy 5-point-scale |
| Self-perception of efficacy greasy aspect | 1 month | Self-perception of greasy 10-point-scale |
| Self-perception of efficacy: dandruff | 1 month | Self-perception of dandruff 5-point-scale |
| Clinical assessment of erythema | 1 month | erythema 0-5 ordinal scale |
Countries
France
Contacts
Primary ContactSayeh POURHAMIDI, pHD
Outcome results
None listed