Status:
COMPLETED
Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium
Lead Sponsor:
Activ'inside
Collaborating Sponsors:
Complife Italia Srl
Conditions:
Telogen Effluvium
Healthy
Eligibility:
FEMALE
18-52 years
Phase:
NA
Brief Summary
The study is aimed to assess the efficacy of a food supplement in reducing hair loss and accelerating the physiological growth in terms of elongation in female subjects showing acute telogen effluvium...
Eligibility Criteria
Inclusion
- Good general health
- Caucasian ethnicity
- All hair type included
- Transient acute telogen effluvium (duration less than 6 months) due to fatigue, seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of normal daily routing, or emotional stress
- Subjects having a positive pull test result
- Subjects with minimum hair length of 6/7 cm
- Subjects who stopped any anti hair loss treatment at least 3 months prior the study
- 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
- Willingness not to dye/blench hair during the 2 weeks preceding each visit
- Willingness not to cut hair for all the study length
- Subjects registered with health social security or health social insurance
- Subjects having signed their written Informed Consent form (ICF) and Privacy Policy for their participation in the study and a photograph authorization
- Subjects able to understand the language used in the investigation centre and the information given
- Subjects able to comply with the protocol and follow protocol constraints and specific requirements
- Willingness to use during all the study period only the product to be tested
- Willingness not to use similar products that could interfere with the product to be tested
- Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.)
- Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial
Exclusion
- Subjects who do not meet the inclusion criteria
- Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre
- Subject who is deprived of freedom by administrative or legal decision or under guardianship
- Subject admitted in a sanitary or social facilities
- Subject who is planning a hospitalization during the study
- Subjects under treatment with food supplements which could interfere with the functionality of the product under study
- Subject has participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential)
- 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
- 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
- Subjects under radiotherapy, chemotherapy at any time
- Subjects under locally pharmacological/non-pharmacological treatment applied on the area of interest monitored during the test
- Subject having food disorders
- Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia…)
- Subject having excessive and/or fluctuating hair shedding for more than 6 months
- History or clinical signs of hyperandrogenaemia
- Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit
- 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
- Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…)
- Scalp surgery (hair transplants, laser) at any time.
- Not menopausal women
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06545552
Start Date
September 30 2024
End Date
January 24 2025
Last Update
June 5 2025
Active Locations (1)
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1
Complife Italia srl
San Martino Siccomario, Italy, 27028