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

NCT05503706 | Unknown

• 1 other identifier: ACR_VICO1BIS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Dandruff

Outcome Measures

Primary Outcomes (1)

• Evaluate the change of squame quantity during the antidandruff treatment

  squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame).

  1 month

Secondary Outcomes (2)

• Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment

  1 month

• Evaluation of the scalp barrier function

  1 month

Interventions

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

dandruff shampoo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

DERMSCAN

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Dandruff

Interventions

selenium disulfide

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Study Officials

• AUDREY GUENICHE, PHD

  L'Oreal

  STUDY CHAIR

Central Study Contacts

Philippe MASSIOT, pHD

CONTACT

0660992467; philippe.massiot@rd.loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

FR (1)