Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
1. September 2026 aktualisiert von: Activ'inside
Clinical Efficacy and Safety of Two Food Supplements on Hair Health in Caucasian Male Subjects With Androgenic Alopecia : a Multicentric, Randomised, Double-blind, Placebo-controlled Clinical Study
The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are:
- Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters.
- Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter.
Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality.
Participants will:
- be randomized to one of three groups : Active 1, Active 2 or Placebo;
- take one capsule daily at breakfast for 84 days;
- attend clinical visits at baseline, Day 42, and Day 84;
- undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements;
- complete a self-assessment questionnaire at follow-up visits;
- be monitored for safety and tolerability throughout the study.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
99
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jessica Lacetera
- Telefonnummer: +39 0382 25504
- E-Mail: jessica.lacetera@complifegroup.com
Studienorte
-
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Cosenza
-
Rende, Cosenza, Italien
- Nutratech S.r.l. - Via Francesco Todaro 20/22
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Ferrare
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Ferrara, Ferrare, Italien
- Complife Italia S.r.l. - Via Mortara 171
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Milan
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Garbagnate Milanese, Milan, Italien
- Complife Italia S.r.l. - Via Signorelli 159
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Milan, Milan, Italien
- Complife Italia S.r.l. - Piazzale Siena 11
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Pavia
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Biella, Pavia, Italien
- Complife Italia SRL - Corso San Maurizio 25
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San Martino Siccomario, Pavia, Italien
- Complife Italia S.r.l. - Via Monsignor Angelini 21
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Kontakt:
- Jessica Lacetera
- Telefonnummer: +39 0382 25504
- E-Mail: jessica.lacetera@complifegroup.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Healthy male subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 35 and 65 years (extremes included)
- Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
- Subjects with hair that is at least 5-7 cm long
- Subjects with visible grey or white hair
- Subjects registered with national health service
- Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
- 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
- Subjects who commit not to change their daily routine or lifestyle during the study*
- Subjects on 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
Subjects informed about the test procedures who have signed a consent form and privacy agreement
- Subjects are asked not to change their usual hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc.) throughout the study
Exclusion Criteria:
- Subjects who do not meet the inclusion criteria
- 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 **
- Subjects participating or planning to participate in other clinical trials
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects that have food intolerances or food allergies to ingredients of the study product
- Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ***
- 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 one month)
- Subjects admitted to a health or social facility
- Subjects planning a hospitalization during the study
- Subjects not able to be contacted in case of emergency
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects who have or have had a history of alcohol or drug addiction
Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
Including oncological diseases, diabetes, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata.
- Including corticosteroid drugs, biological drugs, and cytostatic drugs.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Active product 1
hard shell capsule containing green tea leaf extract (Camellia sinensis (L.) Kuntze, Theaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin
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one capsule per day during breakfast with water for 84 days
|
|
Aktiver Komparator: Active product 2
hard shell capsule containing grape seed extract (Vitis vinifera L., Vitaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin
|
one capsule per day during breakfast with water for 84 days
|
|
Placebo-Komparator: Placebo
hard shell capsule containing maltodextrin
|
one capsule per day during breakfast with water for 84 days
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in anagen hair density
Zeitfenster: 42 and 84 days
|
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
|
42 and 84 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total number of hair in anagen phase
Zeitfenster: 42 and 84 days
|
= (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.
|
42 and 84 days
|
|
Change in telogene hair density
Zeitfenster: 42 and 84 days
|
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
|
42 and 84 days
|
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Number of hair protected against falling out (HPF)
Zeitfenster: 42 ans 84 days
|
(TEAF x SH) - (TEBE x SH) where: TEAF is the number of telogen hair after supplement use ; TEBE is the number of telogen hair before product use; SH is the head surface (580cm2). |
42 ans 84 days
|
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Change in total hair density
Zeitfenster: 42 and 84 days
|
Number of total hairs per cm² using phototricogram (TrichoScan)
|
42 and 84 days
|
|
Change in hair brightness
Zeitfenster: 42 and 84 days
|
Hair brightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta).
The measured parameter is the 8° gloss value (average value of the 5 measures).
|
42 and 84 days
|
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Change in hair colour lightness
Zeitfenster: 42 and 84 days
|
Hair color lightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta).
The measured parameter is the L* parameter (average value of the 5 measures) indicating the hair color lightness (i.e.
lighter or darker hair).
|
42 and 84 days
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-assessment questionnaire
Zeitfenster: 42 and 84 days
|
Subjects are asked to reply to a self-assessment questionnaire to assess the efficacy perceived and the pleasantness of the product.
Responses are provided spontaneously, without external influence.
|
42 and 84 days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Enza Cestone, Dr, Complife Italia Srl
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. September 2026
Primärer Abschluss (Geschätzt)
1. Februar 2027
Studienabschluss (Geschätzt)
1. Februar 2027
Studienanmeldedaten
Zuerst eingereicht
27. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. September 2026
Zuerst gepostet (Tatsächlich)
8. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EC_0000367/2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
confidential data
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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