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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05503706
Other study ID # ACR_VICO1BIS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date December 2022

Study information

Verified date August 2022
Source L'Oreal
Contact Philippe MASSIOT, pHD
Phone 0660992467
Email philippe.massiot@rd.loreal.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Dandruf often has a substantial negative impact on quality of life. The proliferation of Malassezia specie has been shown to be linked to dandruff. Yet, the sebum is essential for the growth of Malassezia restricta. The sebum is mainly constituted by waxes, squalene and triglycerides. The triglycerides are partially transformed in free fatty acids while the squalene can be oxidized. Therefore, the change in lipids can be of interest for dandruff studies. The scalp barrier function of a dandruff scalp is known to be altered and must recover after an antidandruff treatment The aim of this study is to investigate the change of the scalp lipids and TEWL after a 1% selenium disulfide and 1% salicylic acid antidandruff shampoo on dandruff scalp and after a remanence period


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo
dandruff shampoo

Locations

Country Name City State
France DERMSCAN Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
L'Oreal

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05506592 - Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff N/A
Completed NCT02448082 - The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis Phase 2
Completed NCT06436495 - Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects N/A
Recruiting NCT05319444 - Cleansing Device for the Treatment of Scalp and Hair Conditions N/A
Completed NCT05989633 - DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
Completed NCT06052241 - Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics N/A