Status:
COMPLETED
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
Lead Sponsor:
L'Oreal
Conditions:
Scalp Dermatitis
Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 treatmen...
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...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04057950
Start Date
June 1 2019
End Date
March 1 2021
Last Update
April 27 2021
Active Locations (1)
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1
Interteck
Paris, France, 75013