Testing a natural supplement for hair loss in men and postmenopausal women
| ISRCTN | ISRCTN19671217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19671217 |
- Submission date
- 06/05/2025
- Registration date
- 06/05/2025
- Last edited
- 06/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study focuses on a common type of hair loss called androgenetic alopecia (AGA), which affects both men and women. In postmenopausal women, it is referred to as female androgenetic alopecia (FAGA). The goal of the study is to evaluate how effective and well-tolerated a food supplement containing Serenoa repens and Cucurbita pepo (AGA Plus) is in improving hair condition in individuals with mild to moderate AGA or FAGA.
Who can participate?
The study is open to men over 18 years old and postmenopausal women. All participants must have a clinical diagnosis of mild to moderate AGA or FAGA and be eligible for treatment with AGA Plus and other medications.
What does the study involve?
Participants will be involved in the study for six months, during which they will attend three clinical visits: one at the start (baseline), one at three months (optional), and one at six months. They will take one capsule of AGA Plus daily. Dermatologists will assess their hair condition using a 7-point scale, and participants will complete a questionnaire about their experience with the supplement. Hair shedding will also be checked at the three-month visit.
What are the possible benefits and risks of participating?
Participants may experience benefits such as improved hair density and reduced hair loss, along with gaining a better understanding of non-drug treatments for hair loss. Risks are minimal but could include mild stomach discomfort or allergic reactions. The supplement is not recommended for women who could become pregnant, are pregnant, or breastfeeding, and it is not suitable for vegetarians or vegans.
Where is the study run from?
Cantabria Labs Difa Cooper (Italy)
When is the study starting and how long is it expected to run for?
June 2024 to May 2025
Who is funding the study?
Cantabria Labs Difa Cooper (Italy)
Who is the main contact?
Dr Stefano Alfano, Medical Advisor at Cantabria Labs Difa Cooper, stefano.alfano@difacooper.com
Contact information
Public, Scientific, Principal Investigator
Via Milano 160
Presso Cantabria Labs Difacooper
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0003-3070-0289 |
|---|---|
| Phone | +39 3802607820 |
| stefano.alfano@difacooper.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Medical and other records |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of the efficacy and tolerability of a supplement based on Serenoa repens and Cucurbita pepo in men and/or postmenopausal women affected by androgenetic alopecia (AGA or FAGA): a prospective, controlled, real-life study |
| Study objectives | The use of a food supplement containing Serenoa repens and Cucurbita pepo improves the efficacy of treatments (Minoxidil and finasteride) for androgenic alopecia in men and post-menopausal women, if compared to the treatment alone |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Our study was based on a food supplement and was entirely conducted in Italy. Following current Italian legislation, clinical trials based on food supplements and cosmetics do not require formal ethical approval. Anyway, this study was performed following the Helsinki Declaration, each enrolled subject signed an informed consent, and the study received approval from an external ethical committee. |
| Health condition(s) or problem(s) studied | Androgenic alopecia in men and post-menopausal women |
| Intervention | At the baseline patients will be randomized in one of the two groups using online tools, Group A (Minoxidil or Finasteride only), Group B (Minoxidil or Finasteride+ Food supplement). Participants will be involved in the study for six months, during which they will attend three clinical visits: one at the start (baseline), one at three months (optional), and one at six months. |
| Intervention type | Supplement |
| Primary outcome measure | Clinical efficacy will be evaluated by the dermatologist using the GLOBAL ASSESSMENT SCORE (7-Point Score), ranging from +3 to -3: Very Much Improved (+3); Moderately Improved (+2); Slightly Improved (+1); Stable (0); Slightly Worsened (−1); Moderately Worsened (−2); Very Much Worsened (−3) at baseline and 6 months |
| Secondary outcome measures | 1. The degree of acceptability and tolerability will be assessed through a dedicated questionnaire consisting of 2 questions, each scored from 1 to 10 at 6 months 2. After 3 months, hair shedding during the initial phase of treatment will be evaluated following the Hamilton Score (for male) and the Ludwig score (for women). For each patient a representative photo will be taken |
| Overall study start date | 20/06/2024 |
| Completion date | 06/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Group A 85 subjects, Group B 98 subjects |
| Total final enrolment | 183 |
| Key inclusion criteria | 1. Male subjects over 18 years of age and/or postmenopausal women 2. Diagnosis of mild to moderate androgenetic alopecia (AGA or FAGA) 3. Eligible for treatment with AGA Plus and for pharmacological treatment |
| Key exclusion criteria | 1. Subjects with active acute inflammatory conditions of the scalp 2. Patients undergoing pharmacological treatment for AGA or FAGA for more than three months 3. Known allergy to any of the components of the study product 4. Subjects with clinically significant iron deficiency 5. Subjects with clinically significant thyroid dysfunction 6. Subjects with dermatological conditions affecting the scalp such as alopecia areata, seborrheic dermatitis, psoriasis, mycosis, lichenoid lesions, etc. 7. Women of childbearing age and/or pregnant women |
| Date of first enrolment | 20/06/2024 |
| Date of final enrolment | 06/05/2025 |
Locations
Countries of recruitment
- Italy
Study participating centre
Caronno Pertusella
21042
Italy
Sponsor information
Industry
Via Milano 160
Presso Cantabria Labs Difacooper
Caronno Pertusella
21042
Italy
| Phone | +39 3802607820 |
|---|---|
| massimo.milani@difacooper.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 06/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Data are being analysed for a future publication in an international journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Stefano Alfano, stefano.alfano@difacooper.com |
Editorial Notes
06/05/2025: Trial's existence confirmed by Medizioni
