Évaluation de l'Efficacité des Soins du Cuir Chevelu pour l'Élixir Revitalisant Premium
Évaluation des effets du soin du cuir chevelu de l'Élixir Revitalisant Premium
The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
This study aims to enroll 60 healthy adults aged from 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning.
Inclusion criteria include healthy adults defined as individuals without chronic diseases, significant illnesses (including cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant), or allergic constitutions, and who are not currently taking any medication or using any scalp care products.
Exclusion criteria include individuals who are pregnant or breastfeeding, as well as males or females with chronic diseases, significant illnesses, or allergic constitutions, currently using scalp care products, students or employees affiliated with the principal investigator, individuals with scalp wounds, those who have participated in cosmetic product testing, and those who have undergone scalp aesthetic treatments within the past three months.
The participants will be randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with 0.1% caffeine and panthenol); Group 3 uses Base + IGF-1 & FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles; Group 5 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 & FGF-7 (each growth factor at twice the concentration than that in Group 3). Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study. On Day 56, the participants will be asked to fill out a self-assessment form and a hair specialist will also assess the hair and scalp condition at the end of the study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taichung, Taïwan, 433304
- Hungkuang University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- Having symptoms of alopecia, baldness, or self-identified with hair thinning.
- Absence of chronic diseases, major illnesses, or allergies.
- Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
Exclusion Criteria:
- Currently taking any medication or using any scalp care products
- Pregnant or breastfeeding
- Chronic diseases, significant illnesses, or allergic constitutions
- Currently using scalp care products
- Students or employees affiliated with the principal investigator,
- Individuals with scalp wounds
- Participated in cosmetic product testing
- Undergone scalp aesthetic treatments within the past three months.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Group 1: Placebo control
Base formula without caffeine and panthenol |
Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
Expérimental: Group 2: Base formula only
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5). |
Base formula consisting of active ingredients 0.1% caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
Expérimental: Group 3: Base formula plus IGF-1 & FGF-7.
Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL) |
Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
Expérimental: Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles (1E9 particles/mL) |
Base formula plus Centella asiatica and ginger extracellular vesicles (1E9 particles/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
Expérimental: Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL) |
Base formula plus Centella asiatica and ginger extracellular vesicles (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sebum Content
Délai: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape. |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair length
Délai: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
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Hair density
Délai: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair thickness
Délai: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
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Hair loss
Délai: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
|
Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes. |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant self-assessment
Délai: Day 56 (End of the study period)
|
Participants will be asked to fill out an assessment form with score from 0 to 4 for each of the hair and scalp condition evaluated. |
Day 56 (End of the study period)
|
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Hair specialist assessment
Délai: Day 56 (End of the study)
|
A hair specialist will assess the hair and scalp condition of the participant and assign a score from 0 to 4 for each of the evaluated items as well as assign a score of Global Aesthetic Improvement Scale (GAIS) from -1 to 3. |
Day 56 (End of the study)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Conditions pathologiques, anatomiques
- Maladies de la peau
- Hypotrichose
- Maladies des cheveux
- Conditions pathologiques, signes et symptômes
- Maladies de la peau et du tissu conjonctif
- Alopécie
- Peptides
- Acides aminés, peptides et protéines
- Protéines
- Facteurs biologiques
- Protéines sanguines
- Somatomedins
- Peptides semblables à l'insuline
- Peptides de signalisation intercellulaire et protéines
- Facteur de croissance de type insuline I
- Extrait de Centella asiatica
Autres numéros d'identification d'étude
- 25-090-A
Informations sur les médicaments et les dispositifs, documents d'étude
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