Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT05503706
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05503706
Study Brief:
Protocol Section:
NCT05503706