Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks Treatment and 12 Weeks Remanence

Vichy Laboratoires

Status

Active, not recruiting

Conditions

Dandruff

Treatments

Other: Selenium disulfide

Other: Piroctone olamine

Study type

Observational

Funder types

Industry

Identifiers

NCT07133334

VCY 24-011

Details and patient eligibility

About

The goal of this study is to to evaluate and compare the efficacy of the routine "Shampoo + Conditioner " versus " Shampoo alone" immediately after application and after 1 week, 2 weeks, 3 weeks, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase) on subjects with moderate to severe dandruff.

Participants will:

Apply investigationnal products 3 time a week during 4 weeks and neutral or investigational products 3 time a week during 12 weeks Visit the center 9 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products

Full description

Secondary objectives:

To evaluate and compare the Quality of Life (QoL) evolution of the routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase);
To assess and compare the cosmetic properties of routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3 and 4 weeks of use (treatment phase);
To assess the tolerance of routine " Shampoo and Conditioner " versus " Shampoo " alone, during 4 weeks of use.

Enrollment

80 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 (groups must be equilibrating);
Patient with hair length > 2 cm;
Patient 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;
Patient usually using a shampoo 2 to 3 times a week and accepting to follow this rate during the whole study period;
Patient having stopped any possible soothing, anti-dandruff and anti-hair loss treatment (per os or topical) 2 weeks prior to study beginning D-14;
Patient 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 colouring or hair bleaching within one week prior to any study visit.

Exclusion criteria

Subject with psoriasis;
Pregnancy, breast feeding, 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 start of the study;
Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study.
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);
Treatment with any other investigational drug in the 4 weeks prior to study entry.