Effectiveness of a food supplement on hair loss
| ISRCTN | ISRCTN12522754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12522754 |
| Secondary identifying numbers | H.E.HU.TU.NHL00.060.08.00_IT0006541/23 |
- Submission date
- 04/02/2024
- Registration date
- 01/03/2024
- Last edited
- 14/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
The study aims to assess the effectiveness of two doses of a dietary supplement claiming anti hair loss properties on a multi-ethnic panel of volunteers after 28 and 84 days of oral intake.
Who can participate?
Male and female volunteers (multiethnic panel) aged from 18 to 65 years old with brittle and thin hair
What does the study involve?
Participants are asked to attend clinic visits at screening and after 28 and 84 days of food supplement intake. During the screening visit, the principal investigator will inform the participants about the study procedure, risks, and benefits. Only participants giving their informed consent are enrolled in the study. The study staff and the participants then fix the date for the first visit. The participants are then randomly allocated to use one of the two doses of the active food supplement or the placebo products for 84 days. Participants will be divided into three study groups to take either one or two capsules per day of the active food supplement or to take one capsule per day of the placebo food supplement. All the measurements and assessments are carried out using non-invasive procedures. The total duration of each visit is 30 minutes. The study duration is 84 days with one intermediate check at 28 days.
What are the possible benefits and risks of participating?
The potential benefits associated with product use are reduced hair loss and improved hair strength and brightness. Risks associated with the procedures involved in this study are judged as minor. All precautions will be taken to ensure that the risk is the lowest possible. All the measurements carried out are minimally invasive and no side effects are expected from the measurement process.
Where is the study run from?
1. Nutratech srl spin-off Università della Calabria (Italy)
2. Complife Beijing Testing Technology Co., Ltd (China)
When is the study starting and how long is it expected to run for?
November 2023 to June 2024
Who is funding the study?
ROELMI HPC Srl (Italy)
Who is the main contact?
Mrs Ileana De Ponti, ileana.deponti@complifegroup.com
Contact information
Dr Ileana De Ponti
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
 ORCID ID |
0000-0003-0579-7904 |
|---|---|
| Phone | +39 (0)3316841438 |
| ileana.deponti@complifegroup.com |
Study information
| Study design | Multicentric single-blind parallel-group placebo-controlled inter- and intra-group comparison study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Multi-ethnic clinical-instrumental evaluation of the efficacy of two doses of a dietary supplement claiming anti-hair loss properties. A randomized, placebo-controlled study |
| Study acronym | M.E.-hair-loss |
| Study objectives | The study aims to assess the efficacy of two doses of a dietary supplement claiming anti-hair loss properties on a multi-ethnic panel after 28 and 84 days of product intake. |
| Ethics approval(s) |
Approved 10/01/2024, Independent ethics committee for non-pharmacological clinical investigations (Via XX Settembre 30/4, Genova, 16121, Italy; +39 (0)10 5454842; ssinf@messaggipec.it), ref: 2023/19 |
| Health condition(s) or problem(s) studied | 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 |
| Intervention | 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 supplements. The study foresees 84 days of product consumption. Evaluations of the parameters under study are performed at baseline (T0), after 28 (T28) and 84 days (T84) of product intake. According to a previously defined randomization list subjects are divided into three homogenous study groups as follows: 24 subjects take the first dose of the active food supplement 24 subjects take the second dose of active food supplement 24 subjects take the placebo food supplement Each group will include: 12 Caucasian volunteers recruited in Italy of which 6 are female and 6 are male 12 Chinese volunteers recruited in China of which 6 are female and 6 are male For group who take first dose of active food supplement and the placebo food supplement, the study foresees the intake of one capsule per day in the morning on empty stomach, between meals, with a glass of still water for the 84 days of treatment while for group who take second dose of active food supplement, the study foresees the intake of two capsules per day in the morning on an empty stomach, between meals, with a glass of still water for the 84 days of treatment. A restricted randomization list is created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64-bit Edition (Microsoft, USA) by a biostatistician and stored in a safe place. The randomization sequence was stratified using “Efron’s biased coin” algorithm with a 1:1 allocation ratio. The allocation sequence was concealed from the in-site study director in sequentially numbered, opaque and sealed envelopes, reporting the unblinded treatment allocation (based on the subject entry number in the study). The A4 sheet reporting the unblinded treatment was folded to render the envelope impermeable to intense light. A masked allocation sequence was prepared for the staff delivering the intervention based on the subject entry number in the study. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 10/11/2023 |
| Completion date | 28/06/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/01/2024 |
| Date of final enrolment | 29/03/2024 |
Locations
Countries of recruitment
- China
- Italy
Study participating centres
Nutratech srl spin-off Università della Calabria
Via P. Bucci snc
Rende
87036
Italy
Rende
87036
Italy
Complife Beijing Testing Technology Co.
Beizhan North Street N.17, Room 902- Xicheng District Beijing
Beijing
100089
China
Beijing
100089
China
Sponsor information
ROELMI HPC Srl
Industry
Industry
Via Celeste Milani 24 / 26
Origgio (Va)
21040
Italy
| Phone | +39 (0)2 3351 0150 |
|---|---|
| info@roelmihpc.com | |
| Website | https://www.roelmihpc.com/ |
Funders
Funder type
Industry
ROELMI HPC Srl
No information available
Results and Publications
| Intention to publish date | 29/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository on Complife/Nutratech servers. A backup copy of the raw data will be also in a cloud-based backup server. Tables containing the raw data (output of the measurements) will be also included in the study report and shared with the study sponsor in a pdf file that is electronically signed. The raw data will be stored for a minimum period of 10 years on Complife servers. In the raw data tables, subjects are identified by means of a code generated by the Complife volunteer’s management software. The code is composed of a letter, four digits, and a letter. Access to the study's raw data is allowed only by the study director and the person designated by him to elaborate on the raw data. Elaboration of the raw data includes descriptive statistics (mean and standard error) and inferential analysis (data normality and statistical test). |
Editorial Notes
05/02/2024: Study's existence confirmed by the independent ethics committee for non-pharmacological clinical investigations.
