Androgenic alopecia in men and post-menopausal women Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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