Clinical trial NCT05503706: Effects on the Scalp Lipids and TEWL of a 1% Selenium Disulfide and 1% Salicylic Acid Antidandruff Shampoo on Dandruff Scalp
Official title: Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dandruff
Lead sponsor: L'Oreal
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Exclusion Criteria:

* Main 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
* Main Non-Inclusion Criteria:

  * 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

Primary outcomes:
measure: Evaluate the change of squame quantity during the antidandruff treatment
timeFrame: 1 month
Secondary outcomes:
measure: Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment
timeFrame: 1 month
measure: Evaluation of the scalp barrier function
timeFrame: 1 month
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: DERMSCAN
Study officials:
affiliation: L'Oreal
name: AUDREY GUENICHE, PHD
role: STUDY_CHAIR
References: