Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks

Vichy Laboratoires

Status: Active, not recruiting

Conditions: Dandruff

Treatments: Other: Selenium disulfide

Study type: Observational

Funder types: Industry

Identifiers

NCT07292467

VCY 25-001

Details and patient eligibility

About

The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.

Participants will:

Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products

Full description

=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)

Primary objective :

• To evaluate the reduction of total dandruff ( adherent and non-adherent)

Secondary objectives:

• To evaluate the Quality of Life (QoL) evolution
• To evaluate the reduction of discomfort (itching, stinging, burning sensation)
• To evaluate the reduction of scales
• To assess the cosmetic properties of investigational product
• To assess the tolerance of investigational product

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)

• All types of scalp.

• Any phototype

• Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)

• Severe itching score ≥ 7

• Subject with hair length > 2 cm.

• Subject having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure.

• Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.

• Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:

  • no styling product (tonic, spray, lotion, foam) three days before the study visit.
  • no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil….).
  • no anti-scales products (whatever the type: shampoo, treatment...).
  • no hair coloring or hair bleaching within one week prior to any study visit.

• Subject agreeing not to have a short haircut during the entire study period.

• Subjects in good general and mental health in the opinion of the investigator

• Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form

• Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits

Exclusion criteria

• Subject with scalp psoriasis

• Subject with more than 60% of white hair influencing the scoring of scales.

• Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).

• Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)

• Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.

• Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.

• Subject with history of allergy and/or reactions to latex.

• Subject who has taken:

  • Corticoids (local or per os) within 2 weeks before the study entry
  • Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,
  • retinoid acid (local or per os) since less than 6 months before study entry.

• Subject practicing regularly water sport and/or having regular sauna sessions.

• Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).

• Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles.

• History of drug or alcohol abuse

• History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment

• Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study.

• Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study

• Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)

• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol

• Clinical signs and/or history of immunosuppression

• Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris pectoris)

• Treatment with any other investigational drug in the 4 weeks prior to study entry

• Employee of the sponsor or the study site

Trial design

40 participants in 1 patient group

Shampoo

Treatment:

Other: Selenium disulfide