Acute telogen effluvium from less than 6 months (presenting =15% of telogen parameter at inclusion), with a hair length of at least 5 cm, complaining of brittle and thin hair Skin and Connective Tissue Diseases
Conditions
Interventions
The test product is manufactured according to the applicable national and international rules and regulations. All ingredients included in the product formula are approved for their use in food/food s
Sponsors
ROELMI HPC Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy female (50%) and male (50%) subjects 2. Multi-ethnic panel (50% Asian and 50% Caucasian ethnicity) 3. Aged between 18 and 65 (extremes included) years old 4. All hair types included 5. Subjects showing acute telogen effluvium from less than 6 months (due to fatigue/stress/deficient diet/post-partum/hormonal/fever, etc) 6. Subjects presenting > 15% of telogen parameter at inclusion 7. Subjects with a hair length of at least 5 cm 8. Subjects complaining of brittle and thin hair 9. Subjects who stopped any anti hair loss treatment at least 3 months prior to the study 10. Subjects agreeing not to take any treatment (oral or topic) able to interfere with the hair growth, diameter or fall during the whole study duration 11. Subjects registered with health social security or health social insurance 12. Subjects able to understand the language used in the investigation center and the information given 13. Subjects able to comply with the protocol and follow the protocol’s constraints and specific requirements 14. Willingness to use the same products for hair care during all the study period 15. Willingness not to cut hair for all the study length 16. Willingness not to dye hair during the 4 weeks preceding the T0 visit and during the 4 weeks preceding the T84 visit 17. Subject is aware of the study procedures and has signed an informed consent form, a photograph authorization and privacy information form
Exclusion criteria
Exclusion criteria: 1. Subject does not meet the inclusion criteria 2. Subject is taking part or planning to participate in another clinical study in the same or in another investigation centre 3. Subject is deprived of freedom by administrative or legal decision or under guardianship 4. Subject is admitted to a sanitary or social facilities 5. Subject is planning a hospitalization during the study 6. Subject has participated in another clinical study with anti-hair loss product or treatment within the last 3 months before the inclusion visit 7. Subject is breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) 8. Subject has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 9. Subject 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 10. Subject is in the course of a treatment or intending to have one considered by the Investigator liable to interfere with the study data or incompatible with the study requirements 11. Subject having a skin/scalp condition (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc), liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 12. Subject having a personal history of cosmetic, drug, domestic products or food supplements allergy 13. Subject having food disorders 14. Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia) 15. Subject having excessive and/or fluctuating hair shedding for more than 6 months 16. History or clinical signs of hyperandrogenemia (menstrual cycle >35 days and hirsutism and acne) 17. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit: retinoids, anti-mitotic, cytotoxic drugs other than antineoplastic, anti-androgens (spironolactone, flutamide), androgens, anti-epileptic agents, interferon alpha 18. 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 19. Any other topical treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole…) within the last 2 weeks before the inclusion visit 20. Any following hair care within the last 2 weeks before the inclusion visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm, 21. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…), 22. Radiotherapy, chemotherapy at any time 23. Use of any other product (s) similar to the one in the study 24. Scalp surgery (hair transplants, laser) at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phototrichogram (total hair density [number of total hairs per cm²], telogen hair density [number of hairs in telogen phase per cm²] and proportion [%], anagen hair density [number of hairs in anagen phase per cm²] and proportion [%], hair thickness) measured using TrichoScan® at baseline (T0), 28 days (T28), T84 days (T84) 2. Hair elasticity (maximum elongation before hair breakage) in Caucasian subjects measured using a dynamometer (Tensolab 2512A, Mesdan Lab.) at baseline (T0) and at T84 days (T84) 3. Hair brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at baseline (T0) and at T84 days (T84) 4. Digital pictures acquired using a digital camera at baseline (T0), 28 days (T28) and 84 days (T84) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Product safety assessed using adverse events recording throughout the study (T28 and T84) 2. Product acceptability and volunteers’ perceived efficacy assessed with a self-assessment questionnaire at T84 | — |
Countries
China, Italy
Contacts
Public ContactIleana De Ponti
Outcome results
None listed