Healthy volunteers with acute telogen effluvium Skin and Connective Tissue Diseases
Conditions
Interventions
The active intervention is a food supplement containing hydrolyzed keratin (KerPep®), while the placebo intervention contains the same excipients without the active ingredient. Both the active and the
Sponsors
HKVOR
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female and male healthy subjects (at least 30% male for each group) 2. Age between 18 and 60 years old (extremes included) 3. Caucasian ethnicity 4. Hair length = 5 cm 5. Pull test positive for acute telogen effluvium (more than 10 hairs pulled) 6. Telogen % (phototricogram) = 20% 7. Willingness to use a neutral shampoo (without any claims) during the study period 8. Subjects registered with national health service 9. Subjects certifying the truthfulness of the personal data disclosed to the Investigator 10. Subjects are able to understand the language used in the investigation centre and the information given by the investigator 11. Subjects are able to respect the instructions given by the investigator, as well as able to respect the study constraints and specific requirements 12. 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 13. Commitment not to change the daily routine or lifestyle 14. Subjects providing signed informed consent and privacy documentation
Exclusion criteria
Exclusion criteria: 1. Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc.) 2. Subjects having a scalp lesion in relief which may be traumatized 3. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit 4. Systemic or local androgenetic alopecia treatment or product, taken or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with vitamin B, zinc, caffeine…) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit 5. Any other local treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole…) within the last 2 weeks before the inclusion visit 6. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g., gel, hairspray, wax, foam…) 7. Radiotherapy, chemotherapy at any time 8. Scalp surgery (hair transplants, laser) at any time 9. 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 10. Subjects participating or planning to participate in other clinical trials 11. Subjects deprived of freedom by administrative or legal decision or under guardianship 12. Subjects not able to be contacted in case of emergency 13. Subjects admitted to a health or social facility 14.Subjects planning a hospitalization during the study 15. Subjects who participated in a similar study without respecting an adequate washout period 16.Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 17. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator (e.g. chemotherapeutic agents, anticoagulants, antibiotics, beta blockers, Angiotensin-converting enzyme inhibitors, retinoids, psychotropic medications, etc.) 18. 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 19. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices 20. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Countries
Italy
Contacts
Public ContactVincenzo Nobile
Outcome results
None listed