UnknownNot Applicable

Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff

France60 participantsStarted 2022-10

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male or female volunteers;
✓. Age: 18 to 60 years old included;
✓. Phototype (Fitzpatrick): I to IV;
✓. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
✓. 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;
✓. Subjects exhibiting moderate to severe dandruff status of scalp at screening
✓. Subjects having at inclusion visit Day 0:
✓. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);

Exclusion criteria

✕. Healthy male or female volunteers;
✕. Age: 18 to 60 years old included;
✕. Phototype (Fitzpatrick): I to IV;
✕. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
✕. 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;
✕. Subjects exhibiting moderate to severe dandruff status of scalp at screening and at D-3;
✕. Subjects having at inclusion visit Day 0:
✕. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);

What they're measuring

Analysis of microflora from swabs for fungi quantification

Timeframe: 1 month

Analysis of microflora from swabs for bacteria quantification

Timeframe: 1 month

Analysis of microflora from swabs for bacteria diversity

Timeframe: 1 month

Analysis of microflora from swabs for fungi diversity

Timeframe: 1 month

Trial details

NCT IDNCT05506592

SponsorL'Oreal

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11

Contact for this trial

Sayeh POURHAMIDI, pHD

0660992467 sayeh.pourhamidi@rd.loreal.com

View on ClinicalTrials.gov More Dandruff trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male or female volunteers;
✓. Age: 18 to 60 years old included;
✓. Phototype (Fitzpatrick): I to IV;
✓. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
✓. 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;
✓. Subjects exhibiting moderate to severe dandruff status of scalp at screening
✓. Subjects having at inclusion visit Day 0:
✓. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);

Exclusion criteria

✕. Healthy male or female volunteers;
✕. Age: 18 to 60 years old included;
✕. Phototype (Fitzpatrick): I to IV;
✕. Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
✕. 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;
✕. Subjects exhibiting moderate to severe dandruff status of scalp at screening and at D-3;
✕. Subjects having at inclusion visit Day 0:
✕. total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);

What they're measuring

Analysis of microflora from swabs for fungi quantification

Timeframe: 1 month

Analysis of microflora from swabs for bacteria quantification

Timeframe: 1 month

Analysis of microflora from swabs for bacteria diversity

Timeframe: 1 month

Analysis of microflora from swabs for fungi diversity

Timeframe: 1 month