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Testing a natural supplement for hair loss in men and postmenopausal women

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19671217
Enrollment
183
Registered
2025-05-06
Start date
2024-06-20
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenic alopecia in men and post-menopausal women Nutritional, Metabolic, Endocrine

Interventions

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

Sponsors

Cantabria Labs Difacooper
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Italy

Contacts

Public ContactStefano Alfano
stefano.alfano@difacooper.com+39 3802607820

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026