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

Primary Purpose

Dandruff

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo
Sponsored by
L'Oreal
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dandruff

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • DERMSCAN

Outcomes

Primary Outcome Measures

Evaluate the change of squame quantity during the antidandruff treatment
squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame).

Secondary Outcome Measures

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
Evaluation of the scalp barrier function
The evaluation of the scalp barrier function was done by Transepidermal Water Loss (TEWL) measurement.

Full Information

First Posted
August 12, 2022
Last Updated
August 15, 2022
Sponsor
L'Oreal
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1. Study Identification

Unique Protocol Identification Number
NCT05503706
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L'Oreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dandruff

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo
Intervention Description
dandruff shampoo
Primary Outcome Measure Information:
Title
Evaluate the change of squame quantity during the antidandruff treatment
Description
squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment
Description
Trans epidermal barrier by instrumental evaluation and lipids by chromatography
Time Frame
1 month
Title
Evaluation of the scalp barrier function
Description
The evaluation of the scalp barrier function was done by Transepidermal Water Loss (TEWL) measurement.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe MASSIOT, pHD
Phone
0660992467
Ext
+33
Email
philippe.massiot@rd.loreal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AUDREY GUENICHE, PHD
Organizational Affiliation
L'Oreal
Official's Role
Study Chair
Facility Information:
Facility Name
DERMSCAN
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie CHARTIER, pHD
Phone
04 72 82 36 56
Ext
+33
Email
SCH@dermscan.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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