Dandruff Clinical Trial
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
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
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | DERMSCAN | Villeurbanne |
Lead Sponsor | Collaborator |
---|---|
L'Oreal |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the change of squame quantity during the antidandruff treatment | squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame). | 1 month | |
Secondary | 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 | 1 month | |
Secondary | Evaluation of the scalp barrier function | The evaluation of the scalp barrier function was done by Transepidermal Water Loss (TEWL) measurement. | 1 month |
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