Female subject with telogen effluvium Skin and Connective Tissue Diseases
Conditions
Interventions
The product under investigation is a cosmetic spray.
Half of the recruited subjects are randomized to receive the active product, while the other half receive the placebo. A restricted randomization l
Sponsors
CELL ACELL
Eligibility
Sex/Gender
Female
Age
18 Years to 68 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Caucasian ethnicity 3. Aged over 18 years old included 4. Subject with telogen effluvium 5. Subjects aware of the study procedures and having signed an informed consent form 6. Subjects registered with National Health Service (NHS) 7. Subjects certifying the truthfulness of the personal data disclosed to the investigator 8. Subjects able to understand the language used in the investigation centre and the information given by the investigator 9. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 10. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study 11. Commitment not to change the daily routine or the lifestyle 12. Subject informed about the study procedures and having signed the privacy policy.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not fit the inclusion criteria. 2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements 3. Subjects participating or planning to participate in other clinical trials 4. Subjects deprived of freedom by administrative or legal decision or under guardianship 5. Subjects not able to be contacted in case of emergency 6. Subjects admitted to a health or social facility 7. Subjects planning a hospitalization during the study 8. Subjects who participated in a similar study without respecting an adequate washout period 9. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications 10. Pharmacological treatment (topic or systemic) known to interfere with the tested product or having effects on metabolism 11. Pharmacological treatment (topic or systemic) known to interfere with the tested product or having effect on metabolism (e.g.: anticoagulants, antidepressants, drugs used to lower cholesterol levels, antiviral drugs and beta-blockers) 12. Cosmetic treatment known to interfere with the tested product (e.g.: shampoo, anti-hair loss food supplements, anti-hair loss serum) 13. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 14. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices 15. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phototricogram analysis at baseline, and after 1 month and 3 months of treatment: 1.1. Total Hair Density (number of total hairs per cm²) 1.2. Telogen Hair Density (number of hairs in telogen phase per cm²) 1.3. Anagen Hair Density (number of hairs in anagen phase per cm²) 1.4. Average thickness (µm) 2. Clinical evaluation of hair shedding on the Sinclair hair shedding scale (grade 1 to grade 6) every week from week 1 to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-assessment questionnaire (polytomous question with four possible answers) after 3 months of treatment | — |
Countries
Italy
Contacts
Public ContactVincenzo Nobile
Outcome results
None listed