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

Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dandruff
• Intervention / Treatment: Other: 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe MASSIOT, pHD; Phone Number: +33 0660992467; Email: philippe.massiot@rd.loreal.com

Study Locations

• France
  • Villeurbanne, France, 69100
    • Dermscan
    • Contact: Sophie CHARTIER, pHD; Phone Number: +33 04 72 82 36 56; Email: SCH@dermscan.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment	Trans epidermal barrier by instrumental evaluation and lipids by chromatography	1 month
Evaluation of the scalp barrier function	The evaluation of the scalp barrier function was done by Transepidermal Water Loss (TEWL) measurement.	1 month

Collaborators and Investigators

• Sponsor: L'Oreal
• Investigators: Study Chair: AUDREY GUENICHE, PHD, L'Oréal

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Scalp Dermatoses; Dandruff; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Protective Agents; Dermatologic Agents; Trace Elements; Micronutrients; Antifungal Agents; Keratolytic Agents; Antioxidants; Salicylic Acid; Salicylates; Selenium; Selenium disulfide
• Other Study ID Numbers: ACR_VICO1BIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No