Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis

NCT04057950 | Completed

• 1 other identifier: 17-00182
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).

Conditions

Scalp Dermatitis; Dermatitis

Keywords

seborrheic dermatitis; microbiota; malassezia; bacteria; diversity

Outcome Measures

Primary Outcomes (1)

• Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks

  Change at 8 weeks versus Baseline at 8 weeks of the squamous scale of the shampoo versus vehicle

  before and after 8 weeks of treatement

Secondary Outcomes (2)

• Change in scalp microbiome (quantification)

  before and after 8 week treatment period.

• change in scalp microbiome (qualification)

  before and after 8 week treatment period.

Study Arms (2)

treating shampoo

ACTIVE COMPARATOR

treating shampoo (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo) 1144628 D cosmetic product

Other: cosmetic product

vehicle

PLACEBO COMPARATOR

1144781 cosmetic product

Other: cosmetic product

Interventions

cosmetic product OTHER

Disulfure de sélénium versus placebo formula

Also known as: vichy dercos

treating shampoo; vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with hair length \> 2 cm.
• Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
• Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
• 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 2 weeks prior to D0.
• Subject usually using seborrheic dermatitis treatments

You may not qualify if:

• Subject with hair length \> 2 cm.
• Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
• Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
• 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 2 weeks prior to D0.
• Subject usually using seborrheic dermatitis treatments
• Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
• Subject who used topic treatment for the scalp (anti-dandruff, anti-hair loss, soothing) or corticosteroid treatment (per os or topical) during the last two weeks before the start of 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 tensioactive agents
• Subject who has taken: corticoids within 2 weeks before the study entrr, or anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive, or lithium-based drugs less than 1 month before the study entry, or retinoid acid (local or per os) since less than 6 months before study entry.
• Subject with cutaneous affection of the scalp other than seborrheic dermatitis (psoriasis, alopecia in vertex, pediculosis, atopic dermatitis …).
• Subject affected by serious, non-stabilized or progressive disease 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.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

Interteck

Paris, 75013, France

Location

MeSH Terms

Conditions

Dermatitis; Dermatitis, Seborrheic

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Yorik DROUAULT, MD

  INTERTECK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 15, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: early 2020

Locations

FR (1)