Effects on the Scalp Lipids and TEWL of a 1% Selenium Disulfide and 1% Salicylic Acid Antidandruff Shampoo on Dandruff Scalp

NCT ID: NCT05503706

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2022-12-31

Brief Summary

The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase

Detailed Description

Dandruf often has a substantial negative impact on quality of life. The proliferation of Malassezia specie has been shown to be linked to dandruff. Yet, the sebum is essential for the growth of Malassezia restricta.

The sebum is mainly constituted by waxes, squalene and triglycerides. The triglycerides are partially transformed in free fatty acids while the squalene can be oxidized. Therefore, the change in lipids can be of interest for dandruff studies.

The scalp barrier function of a dandruff scalp is known to be altered and must recover after an antidandruff treatment

The aim of this study is to investigate the change of the scalp lipids and TEWL after a 1% selenium disulfide and 1% salicylic acid antidandruff shampoo on dandruff scalp and after a remanence period

Conditions

Dandruff

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo

dandruff shampoo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject with hair length > 2 cm.
• Subject exhibiting slight to severe dandruff state of scalp: Total dandruff score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including and adherent dandruff score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent dandruff score, after clinical examination 3 days after the last shampoo performed on D-3.
• Subject with slight itching state of scalp: score before shampoo ≥3 (ranging from 0 to 9,) 3 days after the last shampoo performed on D-3.
• Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
• Subject having stopped any possible antidandruff treatment at least 1 week prior to study pre-inclusion.
• Subject usually using anti-dandruff products.
• Subject agreeing not to use any other cosmetic product on the air (tonic,lacquer, gel, mousse) and not colouring or bleaching hair until the end of study

• Subject with hair length > 2 cm.
• Subject exhibiting slight to severe dandruff state of scalp: Total dandruff score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including and adherent dandruff score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent dandruff score, after clinical examination 3 days after the last shampoo performed on D-3.
• Subject with slight itching state of scalp: score before shampoo ≥3 (ranging from 0 to 9,) 3 days after the last shampoo performed on D-3.
• Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
• Subject having stopped any possible antidandruff treatment at least 1 week prior to study pre-inclusion.
• Subject usually using anti-dandruff products.
• Subject agreeing not to use any other cosmetic product on the air (tonic,lacquer, gel, mousse) and not colouring or bleaching hair until the end of study

• Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
• Subject who has used topic treatment for the scalp (anti-dandruff, antihairloss) or corticosteroid treatment (per os or topical) during the last two weeks before the start of the study.
• Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the 2 weeks prior to the study.
• Subject with personal history of allergy and/or particular reactivity to antidandruff products.
• Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
• Subject who has taken a drug containing lithium, corticoids, during the last month; anti-histaminic, anti-fungal, non-steroidal anti-inflammatory or immunosuppressive drugs during the last 7 days.
• Subject who has taken retinoid acid (local or per os) since less than 6 months.
• Subject with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis, alopecia …).
• Subject affected by serious, non-stabilized or progressive disease (according to the investigator) as diabetes, hypertension, hypothyroidism or hyperthyroidism which may influence the evolution of studied cutaneous state and morphology.
• Subject affected by serious pathology (cancer, immune-depressed)
• Subject who has undergone a surgical operation in the previous month of the study or having planned it during the study.
• Subject, who has started, stopped or changed of hormonal treatment (including contraceptive pill) in the previous 6 weeks.
• Pregnancy or breastfeeding during the last 6 months, ongoing or planned during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

L'Oreal

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AUDREY GUENICHE, PHD

Role: STUDY_CHAIR

L'Oreal

Locations

DERMSCAN

Villeurbanne, , France

Countries

France

Central Contacts

Philippe MASSIOT, pHD

Role: CONTACT

philippe.massiot@rd.loreal.com

0660992467 ext. +33

Facility Contacts

Sophie CHARTIER, pHD

Role: primary

SCH@dermscan.com

04 72 82 36 56 ext. +33

Other Identifiers

ACR_VICO1BIS

Identifier Type: -

Identifier Source: org_study_id