Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2%… (NCT04057950) | Clinical Trial Compass
CompletedNot Applicable
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
France80 participantsStarted 2019-06-01
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks