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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

Primary Purpose

Scalp Dermatitis, Dermatitis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

cosmetic product

About this trial

This is an interventional basic science trial for Scalp Dermatitis focused on measuring seborrheic dermatitis, microbiota, malassezia, bacteria, diversity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• Main Inclusion Criteria:
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
• Main Non-Inclusion Criteria:
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.
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

Interteck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treating shampoo

vehicle

Arm Description

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

1144781 cosmetic product

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in scalp microbiome (quantification)

change in scalp microbiome (quantification by Polymerase Chain Reaction of Staphylococcus, Propionibacterium, Malassezia)

change in scalp microbiome (qualification)

change in scalp microbiome (qualification by Next-Generation Sequencing to evaluate diversities)

Full Information

NCT ID

NCT04057950

First Posted

August 12, 2019

Last Updated

April 26, 2021

Sponsor

L'Oreal

1. Study Identification

Unique Protocol Identification Number

NCT04057950

Brief Title

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

Official Title

Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

September 1, 2019 (Actual)

Study Completion Date

March 1, 2021 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

Detailed Description

Seborrheic dermatitis is a chronic, recurrent, cutaneous inflammatory condition that causes erythema and skin flaking, sometimes appearing as macules or plaques with dry white or moist oily scales. In general, this condition affects patients in good general health. In adults, it commonly occurs in areas with high concentrations of sebaceous glands. The scalp is the most frequently affected area (80-90 percent of the cases). These plaques are usually masked by the hair but covered by abundant dandruff, very visible on the head and even on the clothes. In the severe forms, the dandruff plaques develop into "helmets": they then cover tufts of hair and can cause them to fall. On the scalp, the lesions may range from mild desquamation to brownish crusts affixed to the skin and hair. Some patients report pruritus, particularly if the scalp is affected. Secondary bacterial infection may occur, aggravating erythema and exudate and causing local discomfort. Dandruff is regarded as a mild non-inflammatory form of seborrheic dermatitis. The cause of seborrheic dermatitis is not well understood, but its occurrence appears to be related to the proliferation of commensal Malassezia species. Seborrheic dermatitis often has a substantial negative impact on quality of life and is associated with direct and indirect medical costs. The primary goals of therapy for seborrheic dermatitis are to clear the visible signs of disease and reduce bothersome symptoms, especially pruritus. Seborrheic dermatitis of the scalp is most conveniently treated with shampoos containing antifungal agents, corticosteroids, or keratolytic agent. They have been shown to be effective in the treatment of seborrheic dermatitis, but recurrence is common and that ongoing treatment may be necessary. For this study, the choice of the treatment against seborrheic dermatitis was set to ketoconazole, which is a common treatment that shows efficacy. The purpose of this study is to find a way to ameliorate the quality of life of subjects with seborrheic dermatitis. This trial will evaluate the antidandruff maintenance effect of a 1% selenium sulfide/1% salicylic acid-based shampoo (cosmetic shampoo) versus its vehicle during a 8 week application duration, after the subjects were treated with a classic antifungal treatment for seborrheic dermatitis (in this study, the treatment will be a ketoconazole-based antifungal treatment for 4 weeks in adults with light to moderate seborrheic dermatitis).

6. Conditions and Keywords

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

Scalp Dermatitis, Dermatitis

Keywords

seborrheic dermatitis, microbiota, malassezia, bacteria, diversity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double blind study

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treating shampoo

Arm Type

Active Comparator

Arm Description

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

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

1144781 cosmetic product

Intervention Type

Other

Intervention Name(s)

cosmetic product

Other Intervention Name(s)

vichy dercos

Intervention Description

Disulfure de sélénium versus placebo formula

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

before and after 8 weeks of treatement

Secondary Outcome Measure Information:

Title

Change in scalp microbiome (quantification)

Description

change in scalp microbiome (quantification by Polymerase Chain Reaction of Staphylococcus, Propionibacterium, Malassezia)

Time Frame

before and after 8 week treatment period.

Title

change in scalp microbiome (qualification)

Description

change in scalp microbiome (qualification by Next-Generation Sequencing to evaluate diversities)

Time Frame

before and after 8 week treatment period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: • Main Inclusion Criteria: 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 • Main Non-Inclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yorik DROUAULT, MD

Organizational Affiliation

INTERTECK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Interteck

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Antidandruff maintenance effect Comparison of the antidandruff maintenance effect, after a 4 weeks treatment with ketoconazole, of two shampoos (active versus vehicle) applied during 8 weeks i.e. up to week 12 (principal objective) and during 4 and 6 weeks i.e. at week 8 and week 10 (secondary objective).

IPD Sharing Time Frame

early 2020

Learn more about this trial

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

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