Healthy female and male subjects with mild to moderate damaged hair and with hair shine ranging from luster-less to lustrous Other
Conditions
Interventions
The product under investigation is a food supplement that includes Annurca apple fruit dry extract.
Participants will be randomly assigned, in equal proportions (1:1:1), to one of three treatment gro
Sponsors
EVRA S.r.L.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female and male subjects (50% per gender in each group) 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 60 years (extremes included) 4. Subjects with mild to moderate damaged hair (Total hair damage score based on exposure to risk factors <18). Hair damage is evaluated using a scoring system based on the frequency of exposure to specific damaging practices and environmental factors. Each behaviour is assigned a point value according to its frequency of occurrence . The total score is then used to classify the extent of hair damage: Less than 7: Mild damage; 7 to 18: Moderate damage; 18 or more: Severe damage. 5. Subjects with hair shine ranging from luster-less to lustrous (scores 1–3 on the 5-point Visual Shine Scale). Visual evaluation is performed by the Principal Investigator or designated qualified personnel using a 5-point scale, as follows: 1 = Luster-less (little to no shine) 2 = Somewhat luster-less (slightly lacking shine) 3 = In-between (normal shine) 4 = Somewhat lustrous (slightly shiny) 5 = Lustrous (very shiny) 6. Subjects who commit to refraining from the use of any specialized hair products or topical depilatory agents throughout the study 7. Subjects who commit to not manipulating their hair, while maintaining their usual hairstyle during the study 8. Subjects who commit to using a neutral shampoo during the 2-week washout period prior to the experimental phase and throughout the entire study 9. Subjects registered with National Health Service (NHS) 10. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 11. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 12. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 13. Subjects who commit not to change the daily routine and lifestyle during the study 14. Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 15. Subjects informed about the test procedures who have signed a consent form and privacy agreement
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects with scalp or hair diseases (e.g.: scalp psoriasis, eczema, and seborrheic dermatitis) or other causes of hair loss, including androgenetic alopecia, alopecia areata, or other clinically significant alopecia conditions 3. Subjects who are taking oral contraceptives 4. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study: 4.1. AST or ALT> 2 × unl (upper normal limit) 4.2. Hepatitis, liver cirrhosis, fatty liver requiring treatment 4.3. Serum creatinine > 2 × unl, chronic renal failure, kidney disease requiring dialysis 4.4. Hypertension 4.5. Diabetes mellitus 4.6. Known malignancy within the past 5 years 4.7. Clinically relevant psychiatric conditions 4.8. Infectious skin conditions 4.9. Autoimmune diseases 5. Subjects participating or planning to participate in other clinical trials 6. Subjects who participated in a similar study without respecting an adequate washout period (at least three month) 7. Subjects that have food intolerances or food allergies to ingredients of the study product 8. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator: 8.1. Use of topical hair growth agents within the past month 8.2. Application of steroid preparations to the scalp within the past month 8.3. Use of any of the following drugs within the past month: steroids, cytostatics, vasodilators, antihypertensives, anticonvulsants, beta-receptor blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole, or other agents known to affect hair growth 8.4. Use of oral antiandrogens (e.g., dutasteride, finasteride) within the last 6 months 8.5. Use of any medication known to interfere with hair growth within the past 3 months 8.6. Use of chemotherapeutic 8.7. Use of biologic medicines 9. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least three month) 10. Subjects admitted to a health or social facility 11. Subjects planning a hospitalization during the study 12. Subjects not able to be contacted in case of emergency 13. Subjects deprived of freedom by administrative or legal decision or under guardianship 14. Subjects who have or have had a history of alcohol or drug addiction 15. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 16. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hair gloss (arbitrary units) measured using a spectrophotometer/colorimeter CM 700D (Konica Minolta) (the 8° gloss parameter is measured) at baseline and 56, 112 and 168 days of treatment 2. Hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 3. Anagen hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 4. Telogen hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 5. Anagen hair (%) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 6. Telogen hair (%) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 7. Anagen/telogen ratio measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 8. Hair vellus density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 9. Terminal hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 10. Hair thickness (µm) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 11.Hair elasticity (%) measured using a dynamometer (C610 Autotensile Tester, LabThink) at baseline and 56, 112 and 168 days of treatment 12.Hair shine visually evaluated by the Principal Investigator and/or designated qualified personnel using a 5-point scale at baseline and 56, 112 and 168 days of treatment 13.Hair structure visually evaluated by the Principal Investigator and/or designated qualified personnel on Scanning Electron Microscopy (SEM) images using a 12-point scale at baseline and 56, 112 and 168 days of treatment 14. Keratin content (µg/mL) measured through in vitro analysis performed on collected hair samples at baseline and 56, 112 and 168 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall scalp condition visually evaluated by the Principal Investigator and/or designated qualified personnel by observing scalp images captured with a dermatoscope and rated using a 7-point Likert scale at baseline and 56, 112 and 168 days of treatment 2. Self-assessment using a self-evaluation questionnaire (multiple choice questions/numerical rating scale from 1 to 10) 56, 112 and 168 days after treatment 3. Complete blood count (red blood cells, leukocyte count, hemoglobin, hematocrit, platelets) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 4. Lactate dehydrogenase (LDH) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 5. GOT transaminase (AST) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 6. GPT transaminase (ALT) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 7. Alkaline phosphatase measured using standard medical laboratory methods at baseline, and after 168 days of treatment 8. Creatinine measured using standard medical laboratory methods at baseline, and after 168 days of treatment 9. Total cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 10. HDL cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 11. LDL cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 12. Triglycerides measured using standard medical laboratory methods at baseline, and after 168 days of treatment 13. Fasting glucose measured using standard medical laboratory methods at baseline, and after 168 days of treatment 14. TSH reflex measured using standard medical laboratory methods at baseline, and after 168 days of treatment 15. Prothrombin time (PT) measured using standard medical laboratory methods at baseline, and after 168 | — |
Countries
Italy, Romania
Contacts
Public ContactRoberta Villa
Outcome results
None listed